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3 months ago

Senior MSAT Tech Transfer Engineer – US Biologics, Boston area

Vacant Positions
Senior MSAT Tech Transfer Engineer USP or DSP– US Biologics

In this role, you will serve as the primary technical support expert for manufacturing processes. With a robust background encompassing more than three manufacturing processes and involvement in multiple process transfers, you will work closely with your supervisor while also demonstrating a strong understanding of the role’s requirements. You are expected to excel in four key aspects of this role, and any questions or issues requiring clarification or advanced technical expertise should be raised by you. Depending on the situation, you may also provide direct supervision or delegate tasks to a unit or team of employees.

Key Responsibilities:

• 50% – Process Transfer and Process Support: You will be responsible for a wide range of functions related to process transfer and process support. This includes developing a deep understanding of processes, conducting gap analyses and FMEA, creating process models, and authoring or reviewing Process Descriptions and Batch Records. You will also handle tasks such as authoring or reviewing planned deviations and change controls, conducting process monitoring (including summarizing and analyzing manufacturing data), drafting campaign summary reports, and performing activities related to lot release. Your role will also involve recommending improvements to MSAT practices and procedures, and you may provide guidance to junior team members on process transfer and support activities.
• 15% – Deviations / Problem Solving / Data Analysis: You will assess major deviations, including those with potential impacts on product quality, as well as post-lot release deviations that could affect multiple products. Your expertise will be critical in identifying potential root causes using a systematic approach. You should be proficient in applying various problem-solving tools such as Fishbone diagrams and Kepner-Tregoe analysis. You will also excel at identifying potential solutions and leading multidisciplinary teams in developing and implementing these solutions. Complex data analysis, including multiple linear regression analysis, and multivariate analysis, will be part of your responsibilities to understand and interpret, applying them as needed.
• 15% – Documentation and Change Assessments: You will independently author and review process descriptions, definitive formulations, batch records, raw material listings, and change controls. You should have the ability to identify and create new documents that facilitate process transfer or support activities. Identifying process changes and assessing the impact of process/equipment or procedural changes on process performance and product quality will also be in your purview. Additionally, you will support the preparation of documentation for regulatory purposes.
• 10% – Represent MSAT: In this capacity, you will act as the representative of MSAT on project teams and liaise with customer technical and quality representatives. You will also represent MSAT in internal teams, such as Deviation and Run Daily Management System meetings, and participate in Customer and Regulatory Audits. Expect regular interactions with site leadership, addressing matters involving various functional areas, divisions, and customers.
• 10% – Training: You will diligently follow all training and policy guidelines established for the facility and adhere to cGMP requirements. Ensuring that your employee training profile is consistently up to date is essential. Regularly monitoring training lists (e.g., ComplianceWire, SAP Learning Portal).

Key Requirements:

• Educational Background: A BSc, MSc, or PhD in a relevant field is preferred. Ideal areas of study include Biological Science, Biochemical Engineering, etc
• Bioprocessing Expertise: You should possess substantial experience in bioprocessing and have personally led technology transfers within your area of expertise. This may encompass activities related to Mammalian cell culture, Upstream Processing (USP) operations, Downstream Processing (DSP), purification development, and GMP (Good Manufacturing Practices) manufacturing operations.
• Industry Experience: Candidates for this role are expected to have significant industry experience ranging from 9 to 13+ years (or 5-7+ years for Ph.Ds) in process development and process scale-up/manufacturing
• Large Scale Manufacturing: Experience in providing support for large-scale manufacturing, with a preference for experience in mammalian-based processes, is highly valuable. You should have a good understanding of current Good Manufacturing Practices (GMP) and be familiar with US and EU regulations.
• Cross-Site and Cross-Functional Experience: Successful candidates should have previous experience working across multiple sites, scales, etc
• Interpersonal Skills: You must demonstrate the ability to work collaboratively and cross-functionally, establishing productive relationships with both internal and external stakeholders at all levels within the organization.

Key Benefits:

• Sign on bonus on first payslip
• Yearly bonus of 10-13%
• Zero sales tax. Zero state income tax
• Hybrid model: 2 days from home
• Pension contribution
• Flight tickets for employee and family members
• Relocation of goods and furniture from abroad to designated address chosen by employee
• 2 months of temporary accommodation
• Support in search of permanent accommodation
• 75% of travel reimbursement to and from work (commute)
• 25 days of leave entitlement
• Discounts for premium insurance
• Additional employee only benefits (can be discussed over a call)

Job Requirements:

– BSc, MSc or PhD in lifesciences – 4-7+ years of Biopharma experience – 3-7+ years of GMP MSAT Tech Transfer and Scale-up in USP/DSP – English – US or CA work permit
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