Pennington, New Jersey

Job Description Summary:

Job Description:

As part of our continued growth, the newly created Associate Director, Formulation Development (Small Molecule) is responsible for leading and directing pre-formulation, formulation development, and clinical supply manufacturing activities that support PTC's drug discovery and clinical development programs. This involves providing technical guidance for preclinical and clinical formulation design and selection, leading the physio-chemical characterization of compounds advancing into clinical development and managing external service providers for formulation development and clinical supply manufacturing.

The Associate Director, Formulation Development manages and/or oversees internal and external resources to address PTC's pre-formulation and formulation requirements and related business needs. This includes accountability for ensuring the timely and successful manufacture of clinical supplies. Additional responsibilities include drug product process scale up, technical transfers and planning of manufacturing-related activities.

The incumbent works cross-functionally and serves as the primary liaison between the Formulation team, other PTC departments, external service providers and contract manufacturers on formulation related issues.

This individual may also author and review documents included in various regulatory submissions.

May manage, coaches and mentors one or more formulation scientists.

The Associate Director, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

  • Directs formulation development activities to support IND-enabling and other toxicology studies and early/late stage clinical trials. Trouble shoots formulation/process related issues for drug product.

  • Provides technical input in the physicochemical characterization and selection of solid forms for drug candidates for further development.

  • Establishes the formulation strategy and development plan for pre-formulation and formulation activities for dosage form development in close collaboration with Clinical, Regulatory, Process Chemistry, Analytical, Project Management and other PTC groups. Leverages knowledge of current drug delivery technologies where applicable.

  • Evaluates third party service providers for formulation development and provides input towards their selection as necessary. Collaborates with Business Development, Legal and Quality and facilitates the execution of service agreements. Serves as the primary liaison with formulation development and contract manufacturing sites and with internal and external Quality Assurance groups for assigned projects.

  • Collaborates with CMOs and other outsourced partners to transfer manufacturing processes for drug product and to monitor cGMP batch manufacture.

  • Works with Clinical Supplies group to plan manufacturing campaigns for drug product.

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

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

  • PhD degree in a relevant scientific discipline and a minimum of 10 years progressively responsible experience in a pharmaceutical, biotechnology or related environment OR a Master's degree in a relevant scientific discipline and a minimum of 12 years progressively responsible experience in a pharmaceutical, biotechnology or related environment.

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

  • Strong understanding of physical pharmacy and experience in the formulation development of small molecules including oral dosage forms.
  • Demonstrated expertise in oral dosage form (e.g., tablet, capsule, solution) manufacturing and scale up.
  • Demonstrated knowledge of cGMP.
  • Proven problem-solving skills.
  • Demonstrated ability to develop and deliver presentations to senior management on the current status of projects and at internal and external technical meetings on formulation related technologies and trends, as required.
  • If managing direct reports, demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
  • Proficiency with Microsoft Office.
  • Excellent interpersonal, verbal and written communication skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • 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.

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

  • Experience managing and developing one or more direct reports.
  • Experience using electronic lab notebook.
  • Experience in formulation support work for Drug Discovery.
  • Track record of authorship of pertinent sections of successful regulatory submissions (INDs, CTAs, NDAs, Abbreviated New Drug Applications (ANDAs), MAAs, Investigational Medicinal Product Dossiers (IMPDs)) leading to the commercialization of drug products.
  • Experience providing responses to questions from health authorities with respect to regulatory submissions.
  • Ability to work cross functionally (internally and externally) on strategic, tactical and technical matters.

**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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Pennington, New Jersey

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.

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