Manufacturing Process Scientist

Title: Scientist III

Duration: 12 Months

Location: Framingham, MA (01701)

This position's starting pay is: $85.00/hr.

HM Notes:

• Open to candidates willing to relocate at their own expense: Preference is local
• Remote/Onsite/Hybrid- 100% onsite
• Education: BA Chemical, Biology or Cell Biology
• Must-Have Experience with: Deviation management, Manufacturing systems, Commercial management
• Preferred Experience: Cell culture
• Work Experience: 5-7 (academia & industry)

DEPARTMENT DESCRIPTIONS:

Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

• Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement.

• Anticipate, respond to, and permanently resolve issues that arise during production.

• Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.

• Lead the creation and use of digital process data analytic systems.

Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

KEY RESPONSIBILITIES

• Provide technical support and routine process monitoring for upstream mammalian manufacturing of commercial products.

• Review manufacturing processes, deviations, and/or development and production data.

• Review manufacturing batch records, protocols, and control strategies.

• Provide technical support and data analysis for investigations and deviation resolution.

• Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

• Interact with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.

• Oversee and report on overall manufacturing progress.

• Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinate support from process development teams.

• Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

• Provide CMC support and guidance for product life cycle management.

• Provide technical guidance and train less experienced staff.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

BASIC QUALIFICATIONS

• Bachelor’s degree in engineering or science with 5 - 7 years of experience

OR

• Master’s degree in engineering or science with 3 - 5 years of experience

OR

PhD in engineering or science with 0 – 3 years of experience.

LEADERSHIP QUALIFICATIONS

N/A

PREFERRED QUALIFICATIONS

• Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.

• Experience with biologics mammalian upstream unit operations: vial thaw, seed train, wave reactors, production reactors, harvest and capture column operations. Experience with perfusion cultures is highly preferred.

• Hands-on cell culture experience at laboratory or pilot scale.

• Understanding of cGMP concept and familiar with quality and regulatory framework.

• Proficiency in process data analytics.

• Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, DeltaV Process Data Historian, LIMS, and MES.

• Experience leading projects and/or cross functional teams.

• Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

• Strong communication and technical writing skills. Experience communicating with business partners and senior management.

• Experience with root cause analysis and/or risk assessment

• Experience working with statistical analysis software

• Experience communicating with cross-functional teams and senior management

• Proficient in Microsoft Word, Excel, PowerPoint.

SPECIAL WORKING CONDITIONS:

• Ability to gown and gain entry to manufacturing areas

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.