Associate Director, Analytical Product Lead (Biologics)
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Analytical Product Leader (APL) serves as the owner of the analytical lifecycle for approved products within AS&T.
This organization is focused on creating and managing the analytical technical agenda from late stage development and validation (collaboratively with Analytical Development) through ROW (rest of world) & PAS (pre-approval supplement) filings, technical support for quality control laboratories around the world, assessment of method performance in the QC labs, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products.
Duties/
Responsibilities:
Own and drive the analytical technical agenda for the product Single point of contact for all issues related to analytics (except routine QC results) for licensed products Collaborate with analytical development leads, global quality product leads, technical project teams, and regulatory leads to develop and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, stability monitoring, and support of life cycle regulatory filings Collaborating with Analytical Development in the late stages of commercialization through assay validation and transfer, commercial specification setting and regulatory filings Coordinating analytical support during preparation of Initial, ROW, & PAS filings and to collaborate with analytical development in addressing FUMs and PMCs Supporting analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs Manages analytical activities for commercial programs utilizing a matrix team Prepares and leads the preparation of analytical documents and sections in support of initial, ROW, and PAS regulatory filings Coordinates analytical support during review of filingand to work with analytical development to address FUMs and PMCs Supports the testing of BMS Biologics by both internal and external resources Supports analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs Coordinates optimization and improvement of analytical methods Qualifications Specific Knowledge, Skills, Abilities, etc:
Comprehensive knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners Strong communication and leadership skills in a highly interactive environment.
Education/Experience/ Licenses/Certifications:
PhD or MS, with 5 or 7 years of relevant experience in biophysical and biological analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product in a commercial environment.
Travel:
This position requires up to 25% of travel.
Supervisory
Responsibilities:
This role is an individual contributor role managing in a matrix environment.
This may have direct reports.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1405917.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Analytical Product Leader (APL) serves as the owner of the analytical lifecycle for approved products within AS&T.
This organization is focused on creating and managing the analytical technical agenda from late stage development and validation (collaboratively with Analytical Development) through ROW (rest of world) & PAS (pre-approval supplement) filings, technical support for quality control laboratories around the world, assessment of method performance in the QC labs, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products.
Duties/
Responsibilities:
Own and drive the analytical technical agenda for the product Single point of contact for all issues related to analytics (except routine QC results) for licensed products Collaborate with analytical development leads, global quality product leads, technical project teams, and regulatory leads to develop and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, stability monitoring, and support of life cycle regulatory filings Collaborating with Analytical Development in the late stages of commercialization through assay validation and transfer, commercial specification setting and regulatory filings Coordinating analytical support during preparation of Initial, ROW, & PAS filings and to collaborate with analytical development in addressing FUMs and PMCs Supporting analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs Manages analytical activities for commercial programs utilizing a matrix team Prepares and leads the preparation of analytical documents and sections in support of initial, ROW, and PAS regulatory filings Coordinates analytical support during review of filingand to work with analytical development to address FUMs and PMCs Supports the testing of BMS Biologics by both internal and external resources Supports analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs Coordinates optimization and improvement of analytical methods Qualifications Specific Knowledge, Skills, Abilities, etc:
Comprehensive knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners Strong communication and leadership skills in a highly interactive environment.
Education/Experience/ Licenses/Certifications:
PhD or MS, with 5 or 7 years of relevant experience in biophysical and biological analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product in a commercial environment.
Travel:
This position requires up to 25% of travel.
Supervisory
Responsibilities:
This role is an individual contributor role managing in a matrix environment.
This may have direct reports.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1405917.
Estimated Salary: $20 to $28 per hour based on qualifications.
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