Manufacturing Associate Job at BCForward in Harmans

BCforward is currently seeking a highly motivated Manufacturing Associate for an opportunity in Severn, MD

Position Title: Manufacturing Associate

Location: Severn, MD 21077

Expected Duration: Temp to Hire

Shift: 12PM to 12 AM (2-2-3 rotation)

Pay: $34/hr

Job Description

Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required.

KEY RESPONSIBILITIES:

Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps .Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports .May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP .Generate and revise internal and external documents (SOPs, BRs) .Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment . Recommend equipment and other supply purchases within the production areas .Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions. Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays

• Work closely with various departments and aid other teams as necessary

• Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns

• Participate in facility expansion and equipment validation activities

Education & Experience:

• HS or GED with 4-7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

OR

• Associate’s degree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

OR

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks

• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports

• Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.

• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).

• Able to fluently communicate in English. Exhibits excellent written and oral communication skills.

• Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials

Benefits:

BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.