Scientist Iii, Manufacturing

Thermo Fisher Scientific Inc. Carlsbad , CA 92008

Posted 5 days ago

Location/Division Specific Information

Carlsbad-CA

At Microbial Manufacturing Services (MMS), a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver from process development through commercial supply, the expertise, and resources vital to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading and innovative Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

How will you make an impact?

The Scientist III is a shop-floor manufacturing support and execution for biologics manufacturing processes. From new product introduction through process performance qualification, Specialist III is accountable for keeping technical work on track and driving process improvements in collaboration with multi-functional partners. Success in this role means that patients will receive generation lifesaving therapeutics.

What will you do?

Provide on-the-floor technical support for critical manufacturing operations.

Expertise and ownership of process/product impacting investigations.

Lead batch record drafting in partnership with other multi-functional SMEs.

Provide hands-on training to manufacturing personnel and ensure multi shift cross-training performed by training matrix for personnel qualification on performing process unit operations.

Support Bill of Materials (BOM) generation in collaboration with client and multi-functional SMEs.

Act as manufacturing technical lead for tech transfers and validation readiness.

Lead process optimization change controls using the TrackWise quality system and coordinate with multi-functional team members to supervise actions and complete project implementations.

Author, review and approve documentation including batch records, protocols, and reports.

Lead all aspects of data management and analysis.

Identify and lead continuous improvement projects.

How will you get here?

Technical expertise in a fast-paced and highly technical environment at the groundbreaking of biologics manufacturing. Driving projects to meet daring first-to-market clinical/commercialization timelines while defining standards and driving improvements.

Education and experience

B.S. in life sciences, engineering, or a related field + 2 - 4 years experience

M.S. in life sciences, engineering, or a related field + 1 - 2 years experience

Experience in cGMP cleanroom manufacturing and biologics technical operations

Experience in manufacturing operations, engineering, process sciences roles is highly valued.

Knowledge, Skills, Abilities

Clear technical communication to diverse internal and team members.

Project management skills including proven track record to deliver technical projects.

Expertise in biologics manufacturing including sophisticated technical topics in upstream and downstream.

Experience in FDA, EMA oversight including deviations investigations, Change Controls, CAPAs, and regulatory inspection audits.

Proven track record to solve sophisticated technical issues and perform advanced data analysis in a multi-functional team.

Standout colleague with proven track record to build consensus and drive performance with diverse partners.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.


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Scientist Iii, Manufacturing

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