R&D Technical Services Manager

Nature and Scope

The R&D Technical Services Manager will be responsible for the operation and management of Technical Services functions within R&D. The individual will lead and direct activities associated with technology transfer of commercial products and/or New Products as applicable. The individual is responsible for process related technical investigations on commercial products. The individual will work with the Project Teams to ensure that project timelines are met.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

· Manage and support process development activities of commercial products and new products under development for technology transfer and launches.

· Act as a Tech Services Lead or Manage the Tech Services team representing designated work cell projects.

· Manage and provide technical support for day-to-day process-related operations investigations.

· Author, review, and approve Quality Exception/Deviation reports to satisfy company policies and Quality Assurance requirements.

· Responsible and consulted on production/operations process flows to improve efficiency and production yields.

· Responsible for review and/or approval of technology transfer reports, process validation reports, supplemental validation reports, manufacturing risk assessments, and other technical reports, as applicable.

· Approve the timecards of the reporting employees and their attendance as per company policy.

· Manage laboratory work to support product or process/technical troubleshooting, special investigations and product complaints with sufficient supervision.

· Support FDA deficiency activities and work with Regulatory Affairs for new and existing submissions.

· Work closely with QA management to facilitate internal and external Audit response in a timely manner, especially facilitate/fulfill QA’s need during FDA’s audit or queries as needed.

· Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.

· Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

· Master’s Degree or Ph.D. in pharmaceutical science, analytical chemistry, chemical engineering or equivalent are required.

· Minimum of 7-10 years relevant pharmaceutical industry experience of at least 1-2 years of supervisory management position experience is required.

· Scientific background and solid understanding of process development, scale up, process analytical technology, analytical method development/validation principles.

· Experience in analytical sciences including chromatography and spectroscopic techniques is advantage.

· Excellent oral and written English communication skills.

· Ability to prioritize and perform multiple tasks simultaneously.

· Ability to make decisions independently and with appropriate input.

· Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.

· Flexibility in adapting to multiple therapeutic areas interchangeably.

· Strong computer skills (Word, Excel, PowerPoint, and Outlook).

Physical Environment and Requirements

· Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

· Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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