Description
Essential Responsibilities / Duties- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. May determine/develop methods and procedures and may provide guidance to others.
- Proposes designs and performs various scientific or engineering studies aimed at process development, optimization, scale-up and technology transfer for the efficient commercial manufacture of new or existing drug products.
- Prepares protocols and summary reports for process development research studies and batch manufacturing campaigns. Collaborates with Clinical Manufacturing, Formulation Development, QA/QC, Technical Services, Validation and Facilities Engineering to organize activities associated with protocol execution. May supervise technical staff during execution of experimental studies.
- Propose new solutions for process and equipment selection.
- Develop and aid in PAT implementation for commercial manufacturing.
Qualifications- BS/BA Degree in engineering/sciences with 6-8 years of experience or MS in engineering/sciences with 4-6 years related experience , or Ph.D. in engineering/sciences with 0-1 years of related experience
- Working knowledge of manufacturing processes, validation principles, quality systems, engineering design fundamentals, regulatory expectations and industry trends.
- In depth knowledge of high shear mixing, Tangential Flow Filtration, Lyophilization and Spray Drying is strongly preferred.
- Working knowledge of relevant regulatory requirement of the pharmaceutical industry (e.g., cGMP's, cGLP's, ICH, etc).
- Strong technical writing, verbal communication, interpersonal and problem solving skills.
- Pharmaceutical process or research product development experience preferred.
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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
