Senior Director of Biologics Process Development
4 days ago
Job Overview: Lead and oversee the development, optimization, and tech transfer of bispecific protein therapeutics. Collaborate with internal teams and external Contract Development and Manufacturing Organizations (CDMOs) to prepare for Investigational New Drug (IND) submissions.
Key Responsibilities:
- Develop and implement process development strategies for clinical development pipelines.
- Select, manage, and oversee CDMO partnerships to ensure seamless tech transfer and manufacturing.
- Prepare and oversee IND-enabling activities, including regulatory Chemistry, Manufacturing, and Controls (CMC) sections.
- Lead clinical manufacturing efforts and ensure compliance with regulatory requirements.
Requirements:
- Proven leader with extensive industry experience in biologic CMC and process development at a senior level.
- Experience in selecting and overseeing CDMOs for tech transfer of protein manufacturing, including upstream and downstream methods.
- Knowledge of analytical studies for IND submissions.
- Ability to travel to CDMOs and collaborate with cross-functional teams.
About Stratacuity:
Stratacuity is a professional services firm that connects exceptional biopharmaceutical talent with industry leaders. Our team is dedicated to providing personalized career guidance and support to our clients. We value diversity, equity, and inclusion in the workplace and strive to create a welcoming environment for all employees.
-
Senior Director of Biologics Process Development
2 hours ago
Cambridge, Massachusetts, United States Stratacuity Full timeJob Overview: Lead and oversee the development, optimization, and tech transfer of bispecific protein therapeutics. Collaborate with internal teams and external Contract Development and Manufacturing Organizations (CDMOs) to prepare for Investigational New Drug (IND) submissions.Key Responsibilities:Develop and implement process development strategies for...
-
Cambridge, Massachusetts, United States Stratacuity Full timeJob OverviewStratacuity is seeking a seasoned leader to oversee the development, optimization, and tech transfer of bispecific protein therapeutics. The ideal candidate will lead clinical manufacturing efforts between internal teams and external Contract Development and Manufacturing Organizations (CDMOs) for clinical development preparing for...
-
Cambridge, Massachusetts, United States Repertoire Immune Medicines Full timeAbout the RoleWe are seeking a highly experienced Senior Director/Vice President, CMC to join our team at Repertoire Immune Medicines. As a key member of our leadership team, you will be responsible for advancing our TCR bispecific therapies from lead candidate to clinical development.Key ResponsibilitiesLead CMC Teams: Build and lead effective CMC teams to...
-
Senior Director Process Development
4 weeks ago
Cambridge, Massachusetts, United States Meet Full timeMeet has partnered with a Cambridge biotech leading in cell therapy treatments in the ophthalmology space.Our client recently received regulatory approval for one of their products overseas and is looking to replicate this in the US. They are seeking a tenured Senior Director of Process Development to join their growing team and support the development of...
-
Senior Scientist, Biologics Discovery
3 days ago
Cambridge, Massachusetts, United States Fable Therapeutics Full timeAbout Fable Therapeutics:Fable Therapeutics is a biotechnology company that specializes in developing innovative biologics designed to overcome therapeutic index limitations and channel therapeutic response where and when it matters.The company is powered by cutting-edge structure and sequence-based protein language models, and has a strong focus on...
-
Process Development Senior Principal Scientist
3 months ago
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Senior Vice President of CMC and Process InnovationCompany: Stratacuity: Proven Scientific PlacementLocation: Cambridge, MA (Onsite)Field: Biologics/Protein TherapeuticsOverview: We are in search of a dynamic and experienced Senior Vice President to spearhead the advancement, refinement, and technology transfer of bispecific protein therapeutics...
-
Process Development Senior Scientist
3 months ago
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Process Development Senior Scientist
3 months ago
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Senior Process Engineer I, LNP Manufacturing
1 month ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Cambridge, Massachusetts, United States Biogen Full timeAbout This OpportunityBiogen is seeking a seasoned scientist to lead the Tissue-Enhanced Delivery Technologies group as Director/Head. This role will be responsible for defining the vision and strategy for the unit, providing scientific leadership, and identifying new external partnerships.Key ResponsibilitiesDefine the vision and strategy for the...
-
Lead Scientist in Biological Research
1 week ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeLead Scientist in Biological ResearchA dynamic and well-supported startup backed by Third Rock Ventures is transitioning from stealth mode and is in search of a skilled Lead Scientist to join the Biology pre-clinical team. This position will involve taking charge of the Biology team for a discovery-stage pipeline program(s) that target antibody-mediated...
-
Senior Director/Vice President, CMC
4 days ago
Cambridge, Massachusetts, United States Repertoire Immune Medicines Full timeJob DescriptionWe are seeking a highly experienced and skilled Senior Director/Vice President, CMC to join our team at Repertoire Immune Medicines. This is a unique opportunity to lead our CMC efforts and contribute to the development of novel targeted immune medicines.Key ResponsibilitiesBuild and lead effective CMC Teams to develop and optimize upstream...
-
Senior Manager, Process Optimization
2 weeks ago
Cambridge, Massachusetts, United States Vericel Corporation Full timePosition OverviewVericel Corporation, a frontrunner in innovative therapies for sports medicine and critical burn care, presents a remarkable opportunity for a distinguished operational leader eager to contribute to a thriving commercial entity with a well-established array of advanced cell therapies and specialty biologics. This role reports directly to the...
-
Lead Scientist in Biological Research
1 week ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeLead Scientist in Biological ResearchAn innovative startup backed by Third Rock Ventures is transitioning from stealth mode and is on the lookout for a skilled Lead Scientist to join its pre-clinical Biology team. This role will focus on a discovery-stage pipeline targeting antibody-related diseases. The Lead Scientist will be responsible for spearheading in...
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timePosition Title: Vice President of Biologics and Process DevelopmentCompany: StratacuityLocation: Cambridge, MA (Onsite)Field: Biologics and Protein TherapeuticsOverview: We are in search of a highly qualified Vice President to spearhead the advancement, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical applications....
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timePosition Title: Vice President of Biologics and Protein DevelopmentCompany: StratacuityLocation: Cambridge, MA (Onsite)Field: Biologics and Protein TherapeuticsOverview: We are in search of an accomplished Vice President to spearhead the development, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical advancement. This...
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timePosition Title: Vice President of Biologics and CMC DevelopmentCompany: StratacuityLocation: Cambridge, MA (Onsite)Field: Biologics and Protein TherapeuticsOverview: We are in search of a proficient Vice President to spearhead the advancement, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical trials. This position...
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timePosition Title: Vice President of Biologics and Protein TherapeuticsCompany: StratacuityLocation: Cambridge, MA (Onsite)Field: Biologics and Protein TherapeuticsOverview: We are in search of an accomplished Vice President to spearhead the development, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical advancement. This...
-
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director of Business Development and Search to join our team at GlaxoSmithKline. As a key member of our R&D organization, you will play a critical role in supporting early and late-stage global business development and licensing initiatives.Key ResponsibilitiesLead key activities to...