48 Ofertas de Novartis en España

**Vendor Manager** (**Global Service Delivery Operation)**
**About the role**:
We are looking for an exceptional and inspirational Vendor Manager to manage the Outsourcer Team.
You will lead, inspire and develop the Global Service Delivery Operation (via Outsourcer) to ensure the smooth, consistent and successful delivery of global services.
Leadership, stakeholder management and engagement are critical for the role, because you will be actively managing the end-to-end service delivery and associated functions. We would like you to continuously review and drive transformational change and continuous improvement in order to ensure that best-in-class operations standards are maintained at all times.
You will identify,
influence and effectively manage the implementation process for improvement initiatives using agreed and proven methodologies to drive tangible and impactful improvements.
We understand that work-life balance is a key consideration in the world of today, so with our flexible working arrangements, you will be able to balance your time between your home and other Tenerity offices in a way that works for you, your family and your customers.
**What to expect**:
- To ensure that all product, client and partner launches, campaigns or configuration changes are effectively managed from inception to implementation through the adoption of professional change management processes.
- Plan strategies to ensure the business gains maximum benefits from industry developments and improvements. Constantly evaluate best solutions to deliver against business, client and customer requirements both in the short, medium
- and longer-term driving initiatives to a conclusion
- Partnering with all key stakeholders within agreed frameworks and ensure all planned operations are conducted within budget on an ongoing basis with continuous review and improvement plans in place - i.E. Finance, HR, Commercial and Client and Product teams
- To provide detailed and robust MI (Management Information) that accurately reports on all aspects of outsourcer performance and leadership to ensure consistency in performance
- Management of the Global Service Delivery performance including client service levels, sales and service targets, customer engagement, voice of the customer and satisfaction, quality and all budgetary metrics.
- Ability to effectively management any escalations and complaints in line with client and regulatory standards.
- Ensure the Customer Experience is fully delivered against defined measures.
- Support team members for succession planning and personal development
- To plan and co-ordinate activities with the outsourcer and local teams that motivate staff to achieve KPIs and business metrics
- Review delivery of industry best practise management techniques and routines to ensure delivery of optimal performance
- Maintain and enhance business standards of behaviour and culture in the equitable and fair treatment of team members, ensuring staff conform to all health and safety guidelines, European Time Directive, company policies and regulatory requirement
- Be aware of omni channel as a concept, understand it, promote it and ensure that it is embedded and adopted across the department
**About you**:
- Experience in service delivery industry experience is a bonus
- Experience and direct management of outsourcers or contact centre operations (Spain, Europe)
including where applicable specialist knowledge of regulated business management.
- Health and Safety experience and accountability relevant to business area / size and role
- Financial and commercial awareness, evidence of direct management and budgetary controls
- Strong understanding and experienced user of contact centre technologies
- Strong robust understanding of the Service Delivery and Contact Centre industry
- Robust management and leadership experience across all levels
- CXOne, Avaya / IEX / Kana / Outlook and Word
- Hands on experience of running mid to large scale Service Delivery and Contact Centres
**About Tenerity**:
You’ll work in an open and supportive environment where you’ll be developed, challenged and encouraged to achieve even bigger and better things - nationally and internationally. You’ll learn directly from senior leaders,
from the best in our business. And you’ll enjoy real responsibility, really early on.
Established in the UK in 2007, Webloyalty has since expanded into Ireland, Netherlands, France, Belgium, Spain and Brazil. In 2011, Webloyalty merged with Affinion Group (based in the US), a global leader in customer engagement and loyalty solutions with over 40 years’ experience. Since then Affinion has rebranded to Tenerity and has over 2,000 partners worldwide, including many of the largest and most respected companies in the financial services, retail, travel, and ecommerce sectors.
Every company today talks about supporting diversity and inclusion. But at Webloyalty, these values form an integral part of everythi
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Sr Medical Writer (Drug Development/Late Phase Exp)

Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health

Description

Sr Medical Writer (Drug Development/Late Phase Exp)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but are not limited to:
• Clinical study protocols and clinical protocol amendments;
• Clinical study reports;
• Patient narratives;
• Clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• Investigator brochures, as well as;
• Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health

Description

Sr Medical Writer (Drug Development/Late Phase Exp)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but are not limited to:
• Clinical study protocols and clinical protocol amendments;
• Clinical study reports;
• Patient narratives;
• Clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• Investigator brochures, as well as;
• Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Sr Medical Writer (Drug Development/Late Phase Exp)

Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health

Description

Sr Medical Writer (Drug Development/Late Phase Exp)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but are not limited to:
• Clinical study protocols and clinical protocol amendments;
• Clinical study reports;
• Patient narratives;
• Clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• Investigator brochures, as well as;
• Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Sr Medical Writer (Drug Development/Late Phase Exp) Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health
Description
Sr Medical Writer (Drug Development/Late Phase Exp)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities Mentors and leads less experienced medical writers on complex projects, as necessary.
Acts as lead for assigned writing projects.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents that include, but are not limited to:
Clinical study protocols and clinical protocol amendments;
Clinical study reports;
Patient narratives;
Clinical development plans;
IND submissions and annual reports;
Integrated summary reports;
NDA and (e)CTD submissions;
Investigator brochures, as well as;
Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team providing review comments on draft and final documents.
Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as applicable.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Completes required administrated tasks within the specified timeframes.
Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
Qualifications Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

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We are seeking a skilled Drug Product Development Specialist to join our team in Castilla y León, Spain.

The ideal candidate will be responsible for executing drug product and device development activities of biologic molecules. This includes leading chemical and physical analyses in support of biopharmaceutical product development, providing analytical support for drug product and device development.

• Contribute to diverse projects across a range of biosimilar biomolecules, including antibodies and non-antibodies.
• Evaluate drug product and device development activities and assist with fill & finish operations.
• Perform laboratory tests and procedures in accordance with GLP, cGMP, and SOP standards, analyzing scientific data with precision.
• Carry out assigned analytical tasks with minimal supervision to support drug product and device development activities.
• Perform analytical tests and procedures on candidates for biological drugs, specifically CCIT, FlowCAM, Stoppering & Assembly machine, Microscope FTIR, Rheometer, UTT machine (for medical devices).
• Support the development, qualification, and validation of analytical methods specific to the Formulation and Drug Product Development department.
• Identify technical challenges and effectively troubleshoot instrument problems, suggesting and implementing areas for improvement.
• Prepare detailed study protocols, SOPs, and technical reports in a timely and efficient manner.
• Maintain the organization and equipment of the Formulation and Drug Product Development laboratory.

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Formulation & Drug Product Development Technician for our Manufacturing Site in León (Spain).

General Responsibility

Responsible for proper execution of drug product and device development activities of biologic molecules. Lead chemical and physical analyses in support of biopharmaceutical product development. providing analytical support for drug product and device development. Prioritizes group tasks and manages resources to meet organizational goals.

Specific Responsibilities

• Contribute to a diverse set of projects, for a wide range of biosimilar biomolecules, including antibodies and non-antibodies.
• Evaluate drug product and device development activities and assist fill & finish activities.
• Conduct laboratory tests and procedures in accordance with GLP, cGMP, and SOP standards and accurately analyse scientific data with precision.
• Perform assigned analytical tasks with minimal supervision to drug product and device development activities.
• Perform analytical tests and procedure on candidates for biological drugs, particularly, but not limited, to CCIT, FlowCAM, Stoppering & Assembly machine, Microscope FTIR, Rheometer, UTT machine (for medical devices).
• Support the development, qualification, and validation of analytical methods specific based on the Formulation and Drug product development department.
• Identify technical challenges and effectively trouble-shoots any instrument problems
• and suggests and implements areas for improvement.
• Timely and efficiently prepare detailed study protocols, SOPs and technical reports.
• Actively contribute to the maintenance of Formulation and Drug product development laboratory organization and equipment.
• Train staff on laboratory procedures when required.

Requirements and personal skills

• Education: PhD/Bachelor in relevant Biochemistry/Chemistry specialty.
• Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
• Experience (years/area): 3 – 5 years of drug product, device and analytical experience relevant to the role working with biologics pharmaceuticals and biotech environments.
• Travels: Not required.
• Specific Knowledge : Previous knowledge and hands-on experience with device techniques.
• Personal skills:
• Ability to work successfully under appropriate supervision using scientific judgment and professional competency.
• Excellent problem-solving skills as well as time management and organizational skills.
• Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
• Willingness to work extended and, at times, unusual hours to meet business needs.
• Teamworking skills.

Mabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.