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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Lexington, Massachusetts
job type: Contract
salary: $80.20 - 94.35 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The Materials & Process Scientist for the Raw Material Alternatives Taskforce will act as a technical SME and facilitator to develop a consistent approach for the global implementation of alternative suppliers of raw materials used in manufacturing. He/she will be responsible for developing technical plans to evaluate alternate materials, translating supply mitigation strategies into executable implementation work plans, and partnering with personnel at manufacturing sites to understand and evaluate site-specific material requirements. He/She will be the liaison between Technical process experts (Global manufacturing sciences, local manufacturing sciences, and material qualification) as well as the manufacturing and Quality organizations to ensure implementation progression and uninterrupted manufacturing. This individual will provide global value by centralizing of non-product- and non-site-specific tasks.
This is an individual contributor role with cross-functional leadership responsibilities.
- Compare current and proposed new raw materials, and identify differences and risks to product quality, process performance, and patient safety
- Collaborate cross functionally to define technical requirements and activities needed to implement alternative raw materials based on category of material.
- Standardize the implementation approach of alternatives across multiple manufacturing sites and impacted products.
- Translate supply risks and mitigation proposals into executable tasks and implementation plans at manufacturing site level.
- Serve as the communication pathway between CMC teams and Local sites to project governance for reporting project progress, risks, and issues.
qualifications:
Required
- BS in engineering, life sciences, or related field with a minimum 10 years' experience, MS with a minimum of 8 years' experience, or PhD with 2-5 years' experience in pharmaceutical development and manufacturing (preferred), or experience in medical devices or other adjacent industries
- Experience working in a GMP environment
- Strong project leadership/project management experience with a successful track record of change management projects and processes.
- Strong communication and interpersonal skills.
- Ability to collaborate and work cross-functionally in a global environment.
- Expertise in one or more of the following: single use systems, filters, chromatography resins, chemicals, cell culture media, excipients, elemental impurities analysis, extractable and leachables assessments, dual sourcing of raw materials.
- Working knowledge of GMP biologics manufacturing processes and a comprehensive understanding of dependencies between materials, processes, and final product.
- High level of professionalism and business etiquette when communicating with cross-functional teams, and external suppliers.
- Ability to manage numerous priorities simultaneously
- Lead projects and meetings effectively.
- Ability to influence and interact well with others (customers, peers and others in more senior positions)
- Proficient in the use of Microsoft Office including Word, Excel, Visio, and Power Point
- Apply industry guidelines and applicable technology standards to decision making processes
- Provides leadership on cross-functional teams
- Provides leadership to drive highly complex projects including ones that span multiple sites and products
- Consult and collaborate with cross-functional teams including but not limited to Global Process Sciences, local Manufacturing Sciences, Material Qualification, Quality, Manufacturing, Engineering, Procurement & Supply chain.
- Act as a representative in cross-functional teams, leading the global implementation of alternative suppliers of raw materials used in manufacturing.
- Serve as the communication pathway between CMC teams and Local sites to project governance for reporting project progress, risks, and issues.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Chromatography, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.