Director, Pharmaceutical Formulation Development

POSTED: April 12, 2017
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time
START DATE: Immediate Availability

DUTIES/RESPONSIBILITIES:

Essential Functions

  • Manage all aspects of formulation development including regulatory documentation creation, pre-formulation, formulation development, process scale up coordination, data analysis /reporting writing and regulatory documentation generation.
  • Follow all applicable state and federal laws regarding the operation of a pharmaceutical facility.
  • Responsible for all aspects of pharmaceutical development equipment.
  • Understand and implement all aspects of 2011 FDA Guidelines for Process Validation.

Additional Responsibilities

  • Demonstrate technical proficiency in solid and liquid formulation development and adherence to cGMP and ICH compliance.
  • Serve as formulation development lead or delegate to other staff as appropriate regarding formulation development projects teams and product operational teams.
  • Collaborate with regulatory to support IND filling/amendments on CMC section.
  • Evaluate, justify, recommend and purchase development equipment and supplies.
  • Create, revise, review and approve protocols, supporting development data, and reports associated with process validation.
  • Review and approve stability study protocols.
  • Direct the writing and following of applicable SOPs.
  • Facilitate, collaborate and support the integration of the manufacturing area and facility with other groups internal and/or external to the Purdue GMP Center.
  • Collaborate as needed with Analytical Development staff to ensure project clarity and momentum.
  • Evaluate resource requirements to support projects and assure projects remain within budget.
  • Formulate one and five year plans and as required.
  • Plan, train, and assign work to direct reports.
  • Train direct reports on formulation development job-related functions and technical methods.
  • Establish and review training curricula for the Pharmaceutical Development department to develop a comprehensive formulation development training plan.
  • Determine and maintain departmental budget.
  • Provide recommendations with regard to staff discipline, compensation adjustments, hiring, and termination.
  • Consistently meet and exceed customer expectations.
  • Other duties as assigned.

REQUIREMENTS/QUALIFICATIONS:

Knowledge/Skills/Abilities

  • Demonstrated computer skills (Word, Excel, PowerPoint).
  • Demonstrated leadership skills and experience leading a diverse team.
  • Knowledge of 21 CFR, Parts 210 & 211.
  • Expertise in formulation and process development, process validation, and statistical DOE design.
  • Excellent knowledge of cGMP, ICH, USP and global compedial regulations and guidances, particularly as related to formulation and process development and validation.
  • Proven ability to interact effectively with senior business leaders, service providers, and vendors.
  • Effective verbal and written communication skills (one-on-one, small groups, and formal settings).
  • Ability to coordinate work assignments/activities for direct reports.
  • Ability to utilize good judgement and diplomacy.
  • Ability to maintain confidentiality and exercise discretion on operational matters.
  • Strong organizational skills and ability to multi-task.
  • Ability to work in a fast-paced pharmaceutical environment, able to work flexible schedules on a short quick notice.
  • Favorable security and reference checks (DEA/FBI/Criminal).
  • Experience in analytical testing is preferred.

Education/Experience

  • Bachelor's degree in Pharmacy, Science, or Engineering.
  • Minimum of ten years experience in a pharmaceutical manufacturing environment.
  • PhD will substitute for some pharmaceutical formulation development experience.

APPLICATION INSTRUCTIONS: 

Interested candidates, please submit cover letter and resume to humanresources@prf.org

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