Associate Director, Biologics Drug Product Development Lead

7 days ago

Princeton, New Jersey, United States Otsuka Pharmaceutical Co., Ltd. Full time
Job Summary

As Associate Director, Biologics Drug Product Development, you will oversee the formulation development and fill finish processes for bio-therapeutics, technology transfer to clinical and commercial CDMOs. You will be responsible for strategic oversight and leadership of the full scope of drug product activities for biologics early phase through commercialization.

Key Responsibilities
  • Review and author development reports, comparability protocols, specifications, validation reports, and other technical documents for technical correctness and regulatory compliance.
  • Develop sound, integrated plans for development and manufacturing in collaboration with formulation, analytical, quality, and regulatory SMEs.
  • Provide strategic guidance on regulatory interactions relating to drug product formulation and process development, specifications setting, and control strategy.
  • Manage budgets, schedules, and performance requirements to meet project goals.
  • Ensure effective communication and collaboration with functional CMC leads and external partners.
Requirements
  • Ph.D. preferred in a relevant field (e.g., biochemistry/chemistry, pharmaceutical sciences, chemical engineering) with 10+ years of experience, or equivalent experience in the biopharmaceutical industry.
  • Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking, and flexibility to support multiple development programs simultaneously.
  • Working knowledge of ICH and FDA guidelines and global regulations.
  • Experience with regulatory, QA, and cGMP requirements for biologics.
  • Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
Competencies
  • Accountability for Results
  • Strategic Thinking & Problem Solving
  • Patient & Customer Centricity
  • Impactful Communication
  • Respectful Collaboration
  • Empowered Development

Otsuka Pharmaceutical Co., Ltd. is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

  • Executive Director, Biologics Business Development

    4 weeks ago

    Princeton, New Jersey, United States Celebree School of Sudbury Full time

    Job SummaryCelebree School of Sudbury is seeking a seasoned executive to lead our Biologics Business Development efforts. As Vice President, Head of US Biologics Operations, you will be responsible for driving business growth, developing strategic partnerships, and overseeing the commercialization of our biologics products.Key ResponsibilitiesDevelop and...

  • Associate Director, Global Drug Safety and Pharmacovigilance

    7 days ago

    Princeton, New Jersey, United States Genmab Full time

    Job Title: Associate Director, Global Drug Safety and PharmacovigilanceAt Genmab, we're committed to building a culture of excellence and innovation in the field of drug safety and pharmacovigilance. We're seeking an experienced Associate Director to join our team in Princeton, where you'll play a critical role in ensuring the safety of our products and...

  • Director of Process Development

    7 days ago

    Princeton, New Jersey, United States Life Science People Full time

    Job Title: Director of Process DevelopmentLife Science People is seeking a highly skilled and experienced Director of Process Development to lead our viral vector manufacturing efforts. As a key member of our team, you will be responsible for developing and optimizing processes to ensure the highest quality products.Key Responsibilities:Develop and implement...

  • Director of Process Development

    3 days ago

    Princeton, New Jersey, United States Life Science People Full time

    Director of Process DevelopmentLife Science People is seeking a highly skilled Director of Process Development to lead our viral vector manufacturing efforts. As a key member of our team, you will be responsible for developing and optimizing processes to ensure efficient and scalable production of viral vectors.Key Responsibilities:Develop strategic plans...

  • Lead Statistician for Rare Disease Drug Development

    4 weeks ago

    Princeton, New Jersey, United States ACADIA Pharmaceuticals Inc. Full time

    About the RoleWe are seeking a highly experienced Senior Biostatistics Director to lead our biostatistics team in the development of novel therapies for rare diseases. As a key member of our R&D team, you will be responsible for overseeing the design, execution, and interpretation of statistical analyses for clinical trials.Key ResponsibilitiesStatistical...

  • Director of Process Development and Optimization

    3 weeks ago

    Princeton, New Jersey, United States Life Science People Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Process Development and Optimization to lead our viral vector manufacturing efforts. As a key member of our team, you will be responsible for developing and optimizing processes to ensure the efficient and scalable production of viral vectors.Key ResponsibilitiesProcess Development and...

  • Vice President, Head of US Biologics Operations

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc (USA) Full time

    About the RoleWe are seeking a seasoned executive to lead our Biologics Commercial Team as Vice President, Head of US Biologics Operations. This is a critical role that will drive business growth and revenue targets for our Biologics portfolio.Key ResponsibilitiesLead the Biologics Commercial Team and develop strategic plans to achieve business...

  • Vice President, Head of US Biologics Operations

    4 weeks ago

    Princeton, New Jersey, United States Celebree School of Sudbury Full time

    Job SummaryCelebree School of Sudbury is seeking a seasoned executive to lead our Biologics Business Development efforts. As Vice President, Head of US Biologics Operations, you will be responsible for driving business growth, developing strategic partnerships, and overseeing the commercialization of our biologics products.Key ResponsibilitiesDevelop and...

  • Senior Director of Pharmacovigilance and Drug Safety

    1 week ago

    Princeton, New Jersey, United States ACADIA Pharmaceuticals Full time

    About Acadia PharmaceuticalsAcadia Pharmaceuticals is a leading biopharmaceutical company dedicated to advancing breakthroughs in neuroscience to elevate life. With a rich history of innovation, we have been at the forefront of healthcare for over 30 years, bringing vital solutions to people who need them most. Our commitment to excellence has led to the...

  • Associate Director of Talent Development

    2 days ago

    Princeton, New Jersey, United States Princeton University Full time

    Job Title: Associate Director, Talent DevelopmentPrinceton University is seeking an Associate Director of Talent Development to join its Organizational Effectiveness (OE) team within the Office of Information Technology (OIT).About the RoleThe Associate Director of Talent Development reports to the Senior Director of OE and leads the implementation of...

  • Vice President, Head of US Biologics Operations

    3 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    About Sun PharmaceuticalsSun Pharmaceuticals Industries Inc. is a leading generic pharmaceutical company with a strong presence in the global market. Our mission is to develop and market quality products that bring value to our customers and ultimately the patient.Job SummaryWe are seeking a results-driven and customer-focused individual to join our team as...

  • Regulatory Director

    3 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory...

  • Vice President, Head of US Biologics Operations

    1 week ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    About Sun PharmaceuticalsSun Pharmaceuticals Industries Inc. is a leading generic pharmaceutical company with a strong presence in the global market. Our mission is to develop and market quality products that bring value to our customers and ultimately the patient.Job SummaryWe are seeking a results-driven and customer-focused individual to join our team as...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States Genmab AS Full time

    About the RoleGenmab A/S is seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for developing and executing global regulatory CMC strategies for biological products during early and late-stage development, and lifecycle.Key ResponsibilitiesDevelop and execute...

  • Regulatory Director

    4 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory...

  • Risk Management and Pharmacovigilance Lead

    4 weeks ago

    Princeton, New Jersey, United States ACADIA Pharmaceuticals Full time

    Job SummaryWe are seeking a highly experienced and skilled Director of Risk Management and Safety to join our team at ACADIA Pharmaceuticals. The successful candidate will be responsible for overseeing the development and implementation of our risk management system, ensuring compliance with regulatory requirements and industry best practices.Key...

  • Vice President, Head of US Biologics Operations

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company that specializes in the development, manufacturing, and marketing of high-quality generic and innovative pharmaceutical products. With a strong presence in the US market, we are committed to delivering exceptional value to our customers and...

  • Vice President, Head of US Biologics

    6 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Vice President, Head of US BiologicsSun Pharmaceuticals Industries Inc. is a leading generic pharmaceutical company with a strong presence in the US market. We are seeking a highly experienced and skilled professional to lead our Biologics business in the US.Key Responsibilities:Develop and execute strategic plans to drive business growth and...

  • Regulatory Sciences Associate Director

    2 weeks ago

    Princeton, New Jersey, United States Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our Global Regulatory Sciences team.About the RoleThe Regulatory Sciences Associate Director will be...

  • Associate Director, US Marketing Lead

    1 week ago

    Princeton, New Jersey, United States Ascendis Pharma Full time

    Job Title: Associate Director, US MarketingAscendis Pharma is a dynamic, fast-growing global biopharmaceutical company with a strong presence in the United States, Denmark, and Europe. Our mission is to develop new and potentially best-in-class therapies to address unmet medical needs.About the RoleWe are seeking an experienced Associate Director, US...