Manufacturing Associate

Net2Source; Harmans (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

An innovative firm is seeking an Associate II to support GMP manufacturing processes for biologics. This role involves applying scientific knowledge to solve operational tasks and ensuring compliance with cGMP standards. The ideal candidate will have a strong background in upstream and downstream biologic production, excellent documentation skills, and the ability to work collaboratively across departments. Join a dynamic team where your contributions will directly impact the efficiency and success of manufacturing operations. If you are passionate about biotechnology and eager to make a difference, this is the perfect opportunity for you.

Benefits

Medical insurance

Dental insurance

Vision insurance

Paid Time Off (PTO)

Qualifications

• 4-7 years of experience in biologic production processes under GMP compliance.
• Ability to apply scientific principles to solve operational tasks.

Responsibilities

• Completes Batch Production Records under cGMP and documents processes.
• Troubleshoots process and equipment problems while maintaining equipment.

Skills

Scientific principles application

Documentation skills

Knowledge of cGMP

Team-oriented

English communication

Basic knowledge of QC, Regulatory, QA

Education

High School Diploma or GED

Associate's degree in Scientific, Engineering or Biotech

Bachelor's degree in Scientific, Engineering or Biotech

Job description

Payrate: $32 - $34/hr.

Summary:
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.

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, BPRs). 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.

Skills:

• 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, SOPs, deviation & summary reports.
• Thorough knowledge of current Good Manufacturing Practices (cGMPs), 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 Management.

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

About Aditi Consulting
Aditi is a leading digital engineering services company. We partner with established and emerging enterprises by leveraging borderless talent across three continents to achieve transformative outcomes that will reshape their trajectory.

We lead and support our clients’ efforts to design, build, and operate the products, systems, and processes required to deliver impact by leveraging deep insights, practical knowledge, and human spirit.
To learn more about our services and career opportunities, please visit https://www.aditiconsulting.com , or connect on Facebook, Twitter, LinkedIn.