Analytical Laboratory Manager

POSTED: December 19, 2016
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time, Exempt
START DATE: Immediate Availability

DUTIES/RESPONSIBILITIES:

Essential Functions

  • Manage all aspects of analytical laboratory including method validation, equipment, and data systems.
  • Follow all applicable State and Federal laws regarding the operation of a pharmaceutical facility.
  • Responsible for all aspects of pharmaceutical analytical equipment including but not limited to:  HPLC, GC, stability chambers, gas tanks, dissolution apparatus, FT-IR, UV/Vis, ovens.

Additional Responsibilities

  • Facilitate and integrate the manufacturing area and facility, including the analytical laboratory, with other groups internal and/or external to the Purdue GMP Center.
  • Write and follow applicable SOPs and instruct as needed.
  • Determine and maintain departmental budget.
  • Evaluate, recommend, and purchase laboratory equipment and supplies.
  • Plan, train, mentor, and assign work to direct reports.
  • Provide recommendations with regard to discipline, compensation adjustments, hiring, and termination.
  • Formulate one and five year plans.
  • Assist in commission and validation of laboratory facility.
  • Create, revise, review, and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of GMP starting materials, intermediates, and APIs.
  • Demonstrate technical proficiency in analytical methodology and adherence to cGMP and ICH compliance.
  • Stay current on field of expertise and be knowledgeable about emerging analytical methodology, equipment, and cGMP, ICH, and USP practices.
  • Review and approve Certificate of Analysis, Certificate of Test, and stability studies.
  • Serve as QC lead on analytical projects teams and product operational teams.
  • Collaborate with regulatory to support IND filling/amendments on CMC section.
  • Evaluate resource requirements to support projects, including providing feedback to proposals for customers, and assure projects remain within budget.
  • Train direct reports on QC job related functions and technical methods.
  • Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan.
  • Perform other duties as may be required or necessary, including duties of direct reports when such individuals / resources are not available to complete tasks.
  • Meet customer expectations.
  • Regular attendance is a requirement of this position.
  • Other duties as assigned.

REQUIREMENTS/QUALIFICATIONS:

  • Bachelor's degree in Pharmacy, Science or Engineering.
  • Candidate must have at least five years cGMP analytical experience within the pharmaceutical industry.
  • Experience in a pharmaceutical facility preferred.
  • Demonstrated computer skills (Word, Excel, PowerPoint).
  • Demonstrated leadership skills.  
  • Experience leading a diverse team.
  • Knowledge of 21 CFR, Parts 210 & 211.
  • Experience in a pharmaceutical manufacturing environment.
  • Expertise in analytical method development, analytical method validation, and statistical quality control.
  • Excellent knowledge of cGMP, ICH, USP, and global compendial regulations and guidance's, particularly as related to analytical method 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 more 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.
  • 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).

APPLICATION INSTRUCTIONS: 

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

  • Job Listings

Kurz Purdue Technology Center, 1281 Win Hentschel Blvd., West Lafayette, IN 47906, 765-588-3470

© 2016-17 Purdue Research Foundation | Maintained by Purdue Research Foundation

Trouble with this page? Please contact Purdue Research Foundation by Phone, 765-588-3470, or FAX, 765-463-3501.