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Patheon
Supervisor, QC Analytical (stability team)
St. Louis, MO - USA
Posted January 10, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary
Authors, initiates, reviews stability protocols, writes client update or in process testing summaries and finished study reports.  Ensures scheduling of sample pulls and testing are coordinated and works cooperatively with other stability team members in support of new, ongoing and past study data and protocols.  Performs a variety of duties related to the effective functioning of a Quality Control lab and supports the team by providing ideas and supporting continuous quality improvement efforts. Ensures and conducts proper staff training. Ensures that deliverables are met or expectations are proactively managed towards alternative solutions.
Key Requirements
  1. Oversees, manages, organizes and supports numerous stability protocols and/or studies in support of existing and future customer drug substance and/or drug product.  Guides aspects of the process including initiation, set up and writing of protocol, working with PM and client to reach an acceptable program..
  2. Optimizes efficiency of the working environment of the group. Ensures training of the group is complete. Monitors the quality of the group, and ensuring that project/work assignments get completed on time. Evaluates personnel in a timely manner.
  3. Participates in client meetings supporting and representing the QC laboratory, it’s capabilities and limitation.  Delivers study and lab testing information in a timely and organized fashion.
  4. Authors, reviews and modifies protocols, and in process data.  Writes finished GMP validated reports.
  5. Coordinates sample pulls from protocol requirements with laboratory testing to assure on time gathering of results at each time point.

Qualifications
  • BA/BS degree in a Science related field
  • Five (5) to Eight (8) years of relevant experience in the bio/pharmaceutical industry
  • Extensive knowledge of GMP regulations in a cGMP manufacturing environment
  • Understanding of product stability, stability programs and degradation concepts
  • Supervision of direct reports for 2+ years
  • Experience with analytical, bioanalytical, bioassay and GMP laboratory settings and functions
  • Experience with performing qualification/validation of QC assays and equipment
  • Experience with the initiation of a program, writing of protocol, working with Program Management and clients to reach an acceptable program, scheduling pull dates, managing data and formulating/writing finished report
  • Understanding of analysis and documentation investigations, RCI and CAPA
  • Routine use of MS Excel, MS Powepoint, MS Access, and MS Word is essential.
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Ability to communicate clearly and professionally in writing and verbally

 

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

 

Disclaimer:

 

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

 

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.


Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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