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Patheon
Sr. Engineer, Tech Transfer
St. Louis, MO - USA
Posted March 20, 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
The Patheon St. Louis site is a multi-product and multi-client biopharmaceutical site with manufacturing facilities for biopharmaceutical products (i.e. antibodies, recombinant proteins and enzymes) for both (pre)clinical trials and commercial applications.

The Sr. Tech Transfer Engineer is an expert in his/her field of expertise (cell culturing and/or downstream processing) and is regarded as such within Patheon Biologics and the wider Patheon. The Sr. Tech Transfer Engineer provides technological input in the prospecting phase and in running customer programs. He/She also contributes to defining and shaping Patheon Biologics’ and Patheon’s own technology programs.  He/She is the linking pin between the Operations department and the Process Development (PD) department, responsible for the sound technology transfer.

Key Requirements

The primary responsibility of the Sr. Tech Transfer Engineer can be broken down into the following specific activities;

  1. Attending Internal Team meetings
  2. Attending Core Team meetings (with Client)
  3. Generate the process flow diagrams (PFD) for all programs.
  4. Working with Process Development to define common methodologies for conducting unit operations at the manufacturing scale, and documenting those procedures via template (non-process specific) PFD, SOPs and job aids.
  5. Create the bill of materials (BOM) and assist with the generation of good faith estimates (GFE) for all client programs.
  6. Complete or delegate the supplier material qualification (SMQ) paperwork in accordance with current SOPs for all programs.
  7. Draft or oversee the drafting of manufacturing batch records.
  8. Review and comment on GMP documentation as appropriate (SOP, Tech Transfer Protocols, MBRs, PFDs, etc.)
  9. Identify manufacturing needs with respect to documentation/systems and implement with a high level of independence. Supervise others who are generating GMP documentation and PFDs.
  10. Work with Process Development and customer to design in manufacturability.
  11. Assist with updating Process Development on operational requirements and reviewing of associated documentation.
  12. Help reviewing incoming raw materials for alignment with platform
  13. Responsible for identifying improvements to Tech Transfer system, having a high, intermediate, and moderate complexity
  14. Identify strategic equipment needs due to high level of expertise

Qualifications
  • Bachelor or Master degree in a scientific, preferably engineering, field
  • 7+ years of experience and hands on knowledge of bringing multiple biologic molecules to market
  • Experience in Upstream and or Downstream Processing
  • Experience in developing systems, generating BOMs and performing facility fit analysis of processes for Tech Transfer in Manufacturing
  • Detailed knowledge of GMP and other pharmaceutical regulations from FDA, EU, ICH and PICs guidelines.
  • Demonstrated success in running multiple projects of high complexity would be ideal
  • Strong customer facing skills preferred.
  • Demonstrated ability to lead teams


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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