• Manufacturing Formulation Specialist

    ThermoFisher Scientific (Plainville, MA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards

    Job Description

    Manufacturing Formulation Specialist

     

    **Location:** Plainville, Ma

     

    Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

     

    What will you do?

     

    Serve as the conduit and catalyst for complete alignment between all MFG shifts. Ensure that all teams have the information needed to perform tasks safely, effectively, and efficiently. Be a subject matter expert in Deviation intakes, Batch Record comments, Client Comments, and Compliance documentation and transfer that knowledge between shifts. Lead successful deployment of process improvements, quality systems and standards.

     

    **Work Hours:** Monday-Friday shift. May require overtime due to business needs.

    Expectations:

    + Act as a Manufacturing (MFG) liaison for cross-functional project support. Ensure high levels of communication with MFG teams, support resources and management regarding operational readiness and the deployment of Quality Systems and Standards.

    + Follow company policies including; safety, training, GDP (Good Documentation Practices), clean room gowning, attendance, and PTO (Paid Time Off).

    + Acts as manufacturing subject matter expert (SME) for assessments in deviations, Batch Lot Verification (BLV), Batch record review, change controls, validation protocols, and document changes. Organize and lead ad-hoc cross functional teams to manage implementation of CAPAs and change controls.

    + Support tech transfer and operational readiness by identifying issues and communicating operational events as needed for on-shift supervisors, managers, and staff.

    + Support MFG record and logbook review within Devops.

    + Address client comments for batch record reviews in a professional and compliant manner while protecting the company’s brand.

    + Support audit readiness activities for manufacturing and ensure audits run smoothly.

    + Serve as SME/QT for manufacturing review of all GMP documents (Batch Record, Logbook, etc.)

    + Maintain and report on organizational metrics and key performance indicators in alignment with department and product supply goals.

    + Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems. Instill strong ownership and accountability by participating in at least two Practical Process Improvement (PPI) Projects every year.

    + Lead implementation of site projects. Engage with technical leadership, program management and clients to implement product / process improvements; lead mfg in cross functional projects by participating in Kaizens and other Process Improvement Projects.

     

    How will you get here?

    Education:

    + Minimum of a High School Diploma/GED with > 5 years Manufacturing experience (preferably within pharmaceutical industry)

    + Bachelor's Degree and 3-7 years of related work experience in a pharmaceutical work environment is preferred

    Experience:

    + Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process

    + Expertise in managing small and medium technical and/or capital projects

    + Demonstrated ability to present ideas persuasively and negotiate effectively

    + Strong planning, organization and multitasking skills

    + Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community

    + Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups

    + Solid understanding of applicable regulatory requirements.

    Knowledge, Skills, Abilities:

    + Ability to function in a dynamic environment and balance multiple priorities simultaneously

    + Ability to learn new software and tools quickly

    + Ability to make decisions and work with minimal to moderate supervision

    Physical Requirements:

    + Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear.

    + Gown aseptically and/or sterile gown as needed.

    + The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time.

    + The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours.

    + Specific vision abilities required by this job include close vision and ability to adjust focus with tasks

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.