In this newly created role, the Senior Director, Formulation Development is responsible for providing strategic and technical leadership to the Formulation Development group which supports PTC’s Drug Discovery, preclinical and clinical development programs. She/He will manage the Formulation group’s resources to adequately support PTC’s dynamic needs.
The Senior Director, Formulation Development manages internal and external resources to address PTC’s preformulation and formulation requirements and related business needs. This includes, but may not be limited to, accountability for: ensuring the timely and successful manufacture of drug product to support clinical studies; drug product process transfers; planning drug product manufacturing-related activities and driving formulation strategies.
She/He manages direct reports.
The incumbent works cross-functionally with internal departments, external service providers and contract manufacturers on formulation-related issues. The Senior Director, Formulation Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. This individual will also author and/or review documents for various regulatory submissions.
Note: This position will initially be based at our Bridgewater NJ, but will move to our Hopewell NJ facility during the third quarter of 2020.
Ensures that prompt and adequate formulation support is provided to Drug Discovery programs for pharmacokinetic, pharmacology and toxicology studies. Collaborates with Drug Discovery to ensure that developability considerations are incorporated in the selection of drug candidates.
Accountability for formulation development activities to support IND-enabling and other toxicology studies and early/late stage clinical trials.
Ensures phase-appropriate physicochemical characterization and selection of solid forms for drug candidates for further development.
Establishes a sound formulation strategy and development plan for preformulation and formulation activities for dosage form development in close collaboration with Clinical, Regulatory, Process Chemistry, Analytical, Technical Operations, Agile teams and other PTC groups. Leverages knowledge of current drug delivery technologies where applicable.
Identifies third party service providers for formulation development and provides a solid outsourcing strategy which will meet PTC’s short-term and long-term needs. Collaborates with Business Development, Legal and Quality and facilitates the execution of service agreements.
Accountable for ensuring a robust manufacturing plan for clinical supplies and for the transfer manufacturing processes for drug product to contract manufacturing facilities.
Manages, coaches and mentors direct reports. Conducts FTE and resource assessment on an ongoing basis to balance workload and resources.
Conducts risk assessment on clinical formulations to ensure clinical objectives are achieved for rare diseases programs in a fast-paced environment.
Provides regular and cogent updates to management on issues, actions, progress and strategies.
Fosters an environment of continuous improvement and education in the Formulation Development group and keeps the group abreast with the latest formulation and manufacturing technologies.
* Minimum level of education and years of relevant work experience.
PhD degree in pharmaceutical, biotechnology, chemistry or related discipline and a minimum of 9 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR a Master’s degree in these same disciplines and a minimum of 12 years of relevant experience in these same environments.
* Special knowledge or skills needed and/or licenses or certificates required.
Experience managing and developing a group of scientists.
Strong understanding of physical pharmacy and demonstrated experience in development of oral dosage forms, with expertise in solids.
Knowledge of cGMP.
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.
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.
Proficiency with Microsoft Office.
Excellent 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.
Prior experience in formulation support work for Drug Discovery.
Agile methodology experience is preferred.
Experience with technical project management is desirable.
Working knowledge of formulation of large molecules/biologics is desirable.
* Travel requirements
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.