Senior Process Development Engineer in Woburn, MA at APEX Systems

Date Posted: 1/16/2020

Job Snapshot

Job Description

Job #:  1036533
Senior Process Development Engineer/ Senior Scientist 1036533
Job Scope and Purpose:
Our Greater Boston area client is seeking a Senior Engineer/Senior Scientist to play a leading role in its lead program, a regenerative program focused on improving hearing function. This hire will play a critical role in lyophilization, process optimization and scale-up for its lead clinical-stage program, and will also contribute to other activities within our client’s platform. To learn more about this exciting and innovative organization, please reach out to Kevin Rees or Todd Jamison!
Primary Job Responsibilities:
  • Lead scale-up activities for the company’s lyophilized Phase 2 clinical product
  • Carry out clinical development activities, including process optimization studies, pilot batch manufacturing and documentation preparation, raw materials availability, and completion of batch records documentation
  • Expand and manage external third-party contractor network and activities
  • Establish drug product stability using Quality by Design principals, including drug release profiles, drug product impurity profiles, product performance criteria, and critical quality attributes
  • Serve as primary product development SME internally and with collaborations
  • As needed, assist in preparing CMC sections of regulatory filings, technical reports, and presentations on the progress of projects
  • As needed, assist in preparing SOPs, specifications, and procedures
  • Oversee and ensure that all GMP clinical materials are manufactured, assayed, shipped and stored in accordance and compliance of regulatory procedures
  • Assist in preparation of commercial manufacturing and launch efforts for our client’s products

Primary Job Requirements:
  • Ph.D. in the applicable area of study with a minimum of 8 years of industry experience; BS-MS candidates with a minimum of 12 years industry experience will also be considered
  • Demonstrated experience in lyophilization is required
  • Extensive experience in formulation manufacturing process development, analytical techniques, design of experiments and other CMC related activities is required
  • Thorough knowledge of drug development processes, regulatory and quality guidelines and submissions
  • Extensive experience with drug product scale-up and manufacturing
  • Previous experience identifying, evaluating and selecting third-party contractors and executing project objectives through these contractors

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
tjamison@stratacuity.com
Code: TechOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.