Senior Analytical Scientist – Product Development (R-SASC)
Location: Rochester, Michigan
As a member of MCP Product Development Team, you will be responsible for supporting the development of new generic and in market products. You will work closely with various teams and departments across the company to support these development activities. The candidate has the opportunity to be an integral part of the formulation and growth of MCP’s Generic Development function. The Sr. Development Scientist coordinates, leads group activities, and develops and implements Department’s short and long-term goals in concert with maintaining site compliance and MCP’s business objectives.
The position provides technical leadership in interdisciplinary teams assembled for various types of projects (e.g., third party product transfers, product scale-up, process development, new product development, etc). As required, the scientist develops teams within the department to support company activities. Other responsibilities include: trouble-shooting technical problems and providing remedial actions; identification and implementation of improvements to analytical methods. The position requires a proactive leader who is accountable and, in partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations
- Provides leadership and guidance to the Product Development Team to ensure project deliverables are met.
- Identifies specification requirements for drug substance, excipients, and drug products.
- Develops an understanding of product stability to guide design of stability studies in support of product registration.
- Develops analytical methods for drug substance, excipients, and drug products (in-process, release and stability)
- Transfers analytical procedures to QC laboratories by directing the validation activities
- Develops and executes protocols for all of the formulation Development activities including Pre-Formulation, Process Development, Material and Component Compatibility, Lyophilization Cycle Development if needed, Reference Listed Drug Assessment, ,
- Generates technical documents to support regulatory submissions, author portions of CMC submissions, and support timely deficiency response and product approval inspections.
- Is able to assess technologies for new drug delivery systems
- Provides leadership in the introduction of 3rd party Development Projects
- Works within a team to define and track project timelines and forecast project resource needs then organizes and oversees all development activities related to assigned projects.
- Investigates and resolves technical problems with currently marketed products.
- Oversees and trains junior staff.
- Identifies new analytical tools and methods and introduces them into practice.
- Works effectively with contract organizations to acquire needed expertise or testing capabilities.
- Provides leadership in the training program of less experienced laboratory staff. The employee may need to be trained in handling controlled substances.
Education / Experience:
A Ph.D. in Chemistry with a minimum of 5 years industry experience in product development is preferred. Candidates with a bachelors or master’s degree in chemistry and at least 10 years of relevant industry experience will also be considered. The candidate must be proficient with modern methods of pharmaceutical analysis- including HPLC, GC, spectroscopic methods, titrimetric methods, compendial wet chemistry techniques, and statistical analysis. The candidate must have sufficient experience in product development to define analytical objectives and resource requirements for a product development project. Experience working with Regulatory and Formulation groups in a project team setting is essential.
- Proficiency in documentation must be demonstrated.
- Understanding of cGMP compliance requirements is essential.
- Experience with structure elucidation tools, or materials analysis is beneficial.
- Familiarity with Waters Empower chromatography software is desirable.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
MCP Pharmaceuticals LLC HR Department, Job Code SAS 870 Parkdale Road Rochester, Michigan 48307
To apply for this position, please Apply Online
About MCP Pharmaceuticals, LLC:
MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.
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