Formulation Scientist

Responsibilities

Coordinate with Project Management in the execution of development projects and with site groups for the introduction of new products.

Comfortable working with external clients, to supplement internal expertise and methodologies, proven ability to recognize internal limitations and make recommendations to external clients.

Interact with cross functional departments including Business Development, Project Management, ARD, QC, Technical Services, Quality Assurance, Operations and external clients.

Develop formulation/manufacturing process from tech transfer to operations in support of GMP manufacturing.

Apply and provide feasibility assessments for a variety of scientific principles and concepts to potential clients, products and investigations.

Conduct experiments which increase the company understanding of products it manufactures or intends to manufacture and conduct literature searches to support formulation development.

Assist, consult and troubleshoot during process transfer scale up and validation activities.

Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, investigation reports, regulatory submissions, master batch records, change control, etc.

Complete and document physical sampling/testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness, friability; sample for analytical and microbiological testing.

Maintain the department laboratories, records, equipment and procedures in line with cGMP.

Responsible to ensure that R&D activities comply with Quality and EHS requirements. Managing and protecting R&D assets as intellectual property. Budgeting and managing expenses.

Develops strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing.

Keeps up to date with current trends and advances in Pharmaceutical sciences for liquids, semi-solids and oral dosage forms.

Qualifications

Required

A minimum of 5+ years of experience for BS or MS and 3-5 years of experience for PhD.

Pharmaceutical formulations development and processing experience in a wide variety of dosage forms, specifically, liquids, semi-solids and oral solid dosage forms.

Experience in MUPS is a bonus. Experience in development, DOE, QbD, statistics and unique technologies is preferred.

Preferred:

Results oriented, driven and accountable

Strong innovative, proactive, hands on orientation

Collaborative and transparent, ability to foster teamwork o Ability to think strategically and execute on strategy

Knowledge of investigational techniques such as RCA and risk assessment

Effective research and problem-solving abilities

Capable of managing multiple projects independently in a fast pace environment o Proficiency in Microsoft Office Suite programs