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Associate Director, CMC Development - Gene Therapy (MA, NJ, or Northeast US/Mid-Atlantic Region remote based) at PTC Therapeutics, Inc.

Posted in Science 30+ days ago.

Type: Full-Time
Location: Lynnfield, Massachusetts





Job Description:

Job Description Summary:

Job Description:

The Associate Director, CMC Development - Gene Therapy is responsible for all aspects of CMC development, from nomination to commercialization, for one or more products in PTC’s gene therapy portfolio. This includes, but may not be limited to, providing strategic and technical leadership for the function and the teams responsible and accountable for phase-appropriate CMC development and execution of manufacturing batches to ensure the supply of pre-clinical, clinical, and commercial material. This role also oversees the strategy and generation of phase appropriate documentation to support regulatory submissions and interactions.

This position works cross-functionally with internal departments and external resources (process and analytical development, manufacturing, project management, quality, and regulatory) on CMC development-related issues to ensure the desired target product profile is achieved.

S/He may manage direct reports.

The Associate Director, CMC Development - Gene Therapy support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

  • Provides strategic and technical leadership for the development and execution of phase appropriate CMC strategies for one or more gene therapy products by managing a cross-functional CMC team which may be comprised of direct and/or indirect reports.

  • Represents CMC on gene therapy program team(s) and works with Research, Nonclinical, Clinical, Regulatory, and program team leadership to ensure CMC strategy aligns with program requirements.

  • Ensures the production of clinical and commercial gene therapy products at internal manufacturing sites and external contract development and manufacturing organizations (CDMOs) meet specifications and are compliant with cGMPs and external regulations.


  • Accountable for building and maintaining effective working relationships with CDMOs and internal manufacturing sites.

  • In conjunction with CMC project management, provides strategic and/or technical guidance as required to guide internal and/or external CMC operations and lifecycle activities such as technology transfer, process development, analytical method development, and qualification and validation activities.

  • Actively contributes to investigations related to the manufacturing processes that may include one or more of the following: upstream, downstream and drug product (fill/finish). Works directly with the manufacturing and quality teams to ensure deviations, non-conformances, and CAPAs are authored as required. Partners with Quality function(s) to address these issues efficiently, effectively, and compliantly.

  • Authors and/or reviews technical CMC documentation as appropriate. This includes, but may not be limited to, technical reports, batch records, protocols and change controls.

  • Authors and/or reviews relevant drug substance and drug product CMC sections for global regulatory submissions (IND/CTA, BLA/MAA, etc).

  • Provides manufacturing feedback on engineering related projects.

  • Actively identifies, recommends, and implements opportunities for continuous improvement.

  • May manage direct reports.


  • Performs other tasks and assignments as needed and specified by management.


Note: This position can be based out of our Lynnfield, MA, Hopewell, NJ facilities or be remote (home based) within the Northeast/Mid Atlantic US region

* Minimum level of education and years of relevant work experience.

  • Ph.D. degree in chemical engineering, bioengineering, biochemistry, or related technical field and a minimum of 6 years of progressively responsible industry experience in biopharmaceutical/biotechnology CMC/Technical Operations or related environment OR a

Master’s degree in chemical engineering, bioengineering, biochemistry, or related technical field and a minimum of 9 years of progressively responsible industry experience in biopharmaceutical/biotechnology CMC/Technical Operations or related environment OR equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

  • Demonstrated knowledge of all aspects of biologic drug development lifecycle with applied experience in one of more of the following: downstream development and manufacturing, or drug product (fill/finish) manufacturing, or analytical method development or validation.

  • Excellent understanding and awareness of regulatory, quality, and CMC requirement for different phases of product development.

  • Demonstrated experience executing cross-functional strategies to supply clinical or commercial drug product

  • Demonstrated experience with scale-up and optimization of lab procedures, up to commercial scale, under GMP conditions.

  • Demonstrated understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Chemistry, Manufacturing and Controls (CMC) aspects of pharmaceutical products.

  • Demonstrated knowledge and application of Pharmaceutical Quality by Design (QbD) principles.

  • Demonstrated experience validating biologic manufacturing processes. Experience authoring CMC sections of regulatory submissions.

  • Experience overseeing/managing CDMOs conducting clinical and commercial manufacturing. Demonstrated ability to motivate and mentor peers and technical staff at CDMOs by fostering a culture of continuous improvement and operational excellence.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects/tasks.

  • Demonstrated leadership skills.

  • Project management skill set with experience in strategic/tactical planning, team building, and budgeting.

  • Ability to influence without direct authority.

  • Proficiency with Microsoft Office.

  • Excellent verbal and written communication and skills including demonstrated technical writing experience. Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner while using tact and diplomacy in interacting with people at all levels in organizations.

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

*Special knowledge or skills and/or licenses or certificates preferred.

  • Small company and/or start-up experience.

  • Experience working in CMC product groups or leading CMC development of gene therapy, cell-based therapies, vaccines and/or biologic products is preferred.

  • Experience with virus or viral vector manufacturing and transfection a plus.

* Travel requirements

10-20%

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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