Job Description

Nature and Scope

Responsible for Process Development, Technology Transfer and Scale Up activities associated with parenteral drug products. Supports cross-functional Production, Engineering, Quality Assurance, and Validation departments trouble shooting of process related manufacturing issues. Supports new process-related equipment for any corresponding capital expansion projects as needed. Support CMC regulatory submission activities.

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.

• Developing, writing, executing and/or reviewing and approving process validation and cleaning validation protocols and reports that support the business needs of the company related to new product development, launch activities, and post approval changes.
• Support the qualification and validation of the pharmaceutical manufacturing processes and ensure that the facility, systems, and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state.
• The incumbent will act as a Subject Matter Expert (SME) for a designated discipline/s. Focusing on Process Validation and Cleaning Validation, the incumbent will develop and execute validation protocols for processes used in the manufacture of aseptically produced parenteral pharmaceuticals.
• Responsible for QbD/process development studies identifying critical process parameters, control strategies and risk assessments of new products under development as well as commercial products.
• Design and implement novel processes and technologies keeping up with industry standards, driving efficiency and cost effectiveness.
• Technical Lead for process related changes for any post approved/ commercial in-line products in support of life cycle management.
• Work with Production, Engineering, Quality Assurance, and Validation departments for new equipment design, URS development, procurement and facility modifications. Coordinate with CMOs for the external Technology Transfers.
• Draft/Review the Engineering Protocols/Reports, Technology Transfer Reports, and Master Batch Records.
• Generate and approve the documents in support of regulatory submissions.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements.
• 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.

• Bachelor’s degree in chemical engineering or Pharmaceutical Chemistry, required
• Minimum of five years progressive work experience in Technical Services encompassing Tech Transfer, Technical Trouble shooting, and process optimization, required.
• Broad knowledge of Process development and scale up of sterile injectable products is essential.
• “Outside the box thinking” and Collaborative mindset is required.
• Hands on skills in Laboratory instruments such as particle sizer, HPLC, Karl Fisher, DSC, etc, are a plus.
• Knowledge of pharmaceutical lifecycle management is a plus.
• Excellent organizational, interpersonal and communication skills are required.
• Proficiency in Microsoft Office Word and Excel is required.

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.
• Position requires working in the laboratory as well as sitting.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Expected Salary Range:

$102,500-107,500

The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

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

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.