Tech Operations Scientist
Proclinical is currently recruiting for a Tech Operations Scientist with a pharmaceutical company located in Gaithersburg, MD.
- Overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace.
- Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large and small molecule).
- Single point of contact for plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site-based documentation, planning, risk management, budget) including launch support.
- Technical input and technical acceptance of Drug Product into the supply chain including cost and robustness metrics through a process of "touch points", thereby ensuring "one voice of the customer" towards R&D and consistency across projects and across plants.
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of technical expertise (e.g., platforms, engineering, SME's) into project execution and QbD technical implementation at the manufacturing site level.
Skills and Requirements:
- A minimum of 7 years of experience and a BS degree, or advanced degree MS/MBA/PhD at least one area within these functions: Small Molecule and/or Large Molecule pharmaceuticals; research and development; Technical Operations; API/ Drug Product Manufacturing; Quality; Regulatory; Drug Development.
- Strong project management skills with experience in supporting the execution of large-scale projects. You should have a sound sense of urgency, process-oriented skills, attention to detail, outstanding teaming and collaboration skills
- Good communication skills including technical writing proficiency
- Ability to lead, encourage and coach project teams and individuals
- Technical & manufacturing background with a detailed aseptic processing understanding, good project management and interpersonal skills
- She or he should also be able work with Health Authorities and technical representatives from Partners and Contract Manufacturers, and to provide answers to HA questions on regulatory documents, ensure technical PAI inspection readiness, etc.
- Knowledge in process validation, equipment qualification and aseptic process equipment requirements
- Lead multi-functional and third-party teams for complex investigations, Tech Transfer and process improvement projects.
- General knowledge of the pharmaceutical industry
- Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP.
- Knowledge of manufacturing site systems and procedures
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 617-830-7544.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.