Kelly Services is looking for a Manufacturing and Science Manager in Princeton, NJ
3 month contract
Pay Rate Negotiable upon experience
- Represents the main technical interface between Novartis and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues.
- Applies an appropriate level of product and process oversight to ensure product quality and process robustness. Performs the technical due diligence in pre-evaluation phase to select the appropriate external suppliers together with BD&L.
- Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy products as well as new development products to external suppliers or between external suppliers.
- Aligns with the Development organization for manufacturing process design during early stage development Acts as the MS&T representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and information transfer within the organization and across functions with focus on process and product know-how.
- · Review respective Quality Risk Analysis (QRA) prior to validation for technical changes.
- · Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
- · Review validation protocol and report as appropriate.
- · Provide all necessary information to generate the validation documentation.
- · Support Validation Lead and Experts to assess need and plan validations, assess revalidation need. Launch & Transfer– for product(s) assigned:
- · Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at external supplier.
- · Provide the necessary data for the technical activities involved in transferring out a product through the appropriate documentation, focusing on existing knowledge. Support technical activities at the giving / receiving site as needed.
- · Define product acceptance criteria for the transfer, agree on acceptable performance with receiving organization and monitor routine manufacturing performance following transfer
- · Ensure successful and well-documented transfers and launches of products with external manufacturing involvement.
- · Active support for Product Launch and Transfer governance processes Interface to Development for the product(s) assigned:
- · Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization site
- · Provide input to formal stage gates during development and up to first APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirements
- · Support development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.). Manufacturing Excellence – for defined product(s):
- · Define and execute design and control optimization projects where needed.
- · Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability. Training:
- · Own the Training Curriculum for its Job Description and direct reports. Novartis Manufacturing Manual:
- · Support implementation of applicable Novartis Manufacturing Manual practices.
- · BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
- · Desirable MSc. or PhD. Languages: Fluent in English. Relevant Experiences:
- · Minimum 5 years of experience in pharmaceutical (chemical) manufacturing.
- · Experience in a global/matrix environment in the pharmaceutical industry
- · Comprehensive know how in pharmaceutical (chemical) technology
- · Project Management experience
- · Drug Development experience
- · Sound experience of data handling and applied statistics
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.