Director, Formulation Development

PTC Therapeutics•Bridgewater, NJ

1d•Onsite

About The Position

The Director, Formulation Development is responsible for leading and directing formulation development and clinical supply manufacturing activities that support PTC’s drug discovery and clinical development programs. This involves preclinical and clinical formulation design and selection, preformulation characterization, process development and scale up and managing external service providers for formulation development and manufacturing. The Director, Formulation Development manages and/or oversees internal and external resources to address PTC’s formulation development and manufacturing requirements and related business needs. This includes accountability for ensuring the timely and successful development and manufacture of phase-appropriate formulations. 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 also authors and reviews technical documents included in various regulatory submissions. She/He may have direct reports. The Director, Formulation Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

PhD degree in a relevant scientific discipline and a minimum of 8 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 10 years progressively responsible experience in a pharmaceutical, biotechnology or related environment.
Strong understanding of physical pharmacy, biopharmaceutics, drug delivery technologies 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.
Ability to influence without authority.
If managing direct reports, demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
Provides support as needed for regulatory submissions or responses.
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.

Nice To Haves

Experience managing and developing one or more direct reports.
Experience using electronic lab notebook.
Experience in formulation support work for Drug Discovery, Clinical Development, & Commercialization.
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.

Responsibilities

Collaborates with PTC's cross-functional working groups and plays a lead role in addressing formulation needs for preclinical & clinical studies and establishing the strategy and development plan for preformulation, formulation, and process development activities.
Establishes the formulation strategy and development plan for preformulation and formulation activities for dosage form development in close collaboration with Clinical, Regulatory, Process Chemistry, Analytical, Project Management and other PTC groups.
Directs and provides technical guidance and oversees formulation activities to support drug discovery & clinical programs, provides developability input in the selection of drug candidates, troubleshoots formulation & process related issues for drug products.
Evaluates third party service providers for formulation development and provides input towards their selection as necessary.
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.
May manage, coach and mentor direct reports.
Performs other tasks and assignments as needed and specified by management.
Manages the general safe working conditions in the laboratories.