Associate Director, Protein Process Development
Location: Boston Area (Onsite)
Science/ Focus: Biologics
Job Overview: Formulate the strategy to drive the execution of late-stage upstream process development/optimization and process characterization for protein therapeutic components
Key Responsibilities:
- Lead a team responsible for upstream process scale-up and technical transfer to external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Analytical, Manufacturing and Quality teams
- Provide technical support for upstream clinical and commercial manufacturing and process validation for protein products as part of a CMC team and act as the SME for protein process science
- Responsible for production of representative protein materials for analytical method development and IND-enabling studies
- Contribute to overall protein process characterization and comparability strategies, study design and data interpretation
- PhD in Chemical Engineering/ Biomedical Engineering with 5+ years of experince in industry (may also consider BS/ MS candidates with extensive experince)
- Strong technical expertise in late-stage upstream process development and scale up for protein manufacturing
- Previous leadership experince with a passion for mentoring and influencing a small growing team
- Experienced with technical transfer to external manufacturing facilities for clinical and commercial manufacturing in collaboration with cross functional teams
- Previous BLA experince for regulatory submissions
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
jditlalia@stratacuity.com
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.