Job Description Summary: The Senior Research Fellow, 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 Senior Research Fellow, 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 Senior Research Fellow, Formulation Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:ESSENTIAL FUNCTIONSPrimary duties/responsibilities:
- Develops robust formulations and manufacturing processes for Phase I-III clinical studies and assists in their transfer to Contract Manufacturing Organizations (CMOs).
- Designs studies and conducts risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
- Conducts process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools. Supports formulation and process technology transfers and scale up to commercial manufacturing sites.
- Conducts troubleshooting of formulation & processing related challenges and recommends potential solutions.
- Develops alternate formulations for current commercial products through life cycle management as required.
- Collaborates with PTC's cross-functional working groups and plays a lead role in addressing formulation needs for preclinical and clinical studies and establishing the strategy and development plan for preformulation, formulation, and process development activities. Leverages knowledge of physical pharmacy, biopharmaceutics, formulation and process design, drug delivery technologies where applicable.
- 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. Leverages knowledge of traditional and enabling drug delivery technologies where applicable.
- Directs and provides technical guidance and oversees formulation activities to support drug discovery and 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. 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.
- May manage, coach and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.
- 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.
* Special knowledge or skills needed and/or licenses or certificates required.
- 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.
- Manages the general safe working conditions in the laboratories.
- 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, 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.
* Travel requirements
*Physical requirements
- Office/laboratory-based position
Expected Base Salary Range: $190,700 - $240,0200. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
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