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Biotech Manufacturing Associate Jobs in Indiana (NOW HIRING)

Danaher

Senior Assembly Associate

Indianapolis, IN · On-site

... biotechnology? At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work ... The Manufacturing Assembly Associate is responsible forprocess monitoring and optimization, quality ...

Biopharma Careers

Associate Scientist II

Indianapolis, IN · On-site

$34.05 - $41.26/hr

... biotech with the global expertise and resources of a leading innovator in oncology. Our mission is ... Experience with Good Manufacturing Processes (GMP) and Good Documentation Practices (GDP) is ...

Bristol-Myers Squibb

Associate Scientist II

Indianapolis, IN · On-site

$34.05 - $41.26/hr

... biotech with the global expertise and resources of a leading innovator in oncology. Our mission is ... Experience with Good Manufacturing Processes (GMP) and Good Documentation Practices (GDP) is ...

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All JobsBiotech Manufacturing Associate JobsBiotech Manufacturing Associate Jobs in Indiana

Biotech Manufacturing Associate information

See Indiana salary details

$11

$19

$31

How much do biotech manufacturing associate jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for biotech manufacturing associate in Indiana is $19.83, according to ZipRecruiter salary data. Most workers in this role earn between $15.58 and $22.21 per hour, depending on experience, location, and employer.

What is a biotech manufacturing associate?

Biotech Manufacturing Associates are professionals who work in the production of biotechnology products, such as pharmaceuticals, vaccines, and other biologically derived materials. They are responsible for operating equipment, following strict protocols, and maintaining sterile environments to ensure product quality and safety. Their duties often include preparing materials, monitoring production processes, troubleshooting equipment issues, and documenting all activities according to regulatory standards. This role is essential in ensuring that biotech products are manufactured efficiently and meet both industry and government regulations.

What are the key skills and qualifications needed to thrive as a biotech manufacturing associate?

To thrive as a Biotech Manufacturing Associate, you typically need a background in biology, chemistry, or a related field, along with experience in GMP-regulated environments. Familiarity with bioprocessing equipment, laboratory instrumentation, and documentation systems such as batch records is crucial. Attention to detail, teamwork, and strong problem-solving abilities help you excel in this collaborative and regulated field. These skills ensure the consistent production of safe, high-quality biotech products while maintaining compliance with industry standards.

What are some common challenges faced by biotech manufacturing associates, and how can they be managed effectively?

Biotech Manufacturing Associates often encounter challenges such as maintaining strict adherence to Good Manufacturing Practices (GMP), troubleshooting equipment malfunctions, and working under tight production deadlines. Effective management of these challenges involves strong attention to detail, proactive communication with cross-functional teams such as quality assurance and engineering, and continuous learning to stay updated on new protocols and technologies. Developing problem-solving skills and embracing a collaborative mindset can also help associates consistently contribute to high-quality production outcomes.

What is the difference between Biotech Manufacturing Associate vs Laboratory Technician?

AspectBiotech Manufacturing AssociateLaboratory Technician
CredentialsHigh school diploma or equivalent; some roles may require associate degreeHigh school diploma or equivalent; some roles may require associate degree or certification
Work EnvironmentManufacturing floor, production lines, cleanroomsLaboratories, research facilities, testing environments
Industry UsageBiotech manufacturing, pharmaceutical productionResearch labs, quality control, testing labs

While both roles support biotech operations, a Biotech Manufacturing Associate primarily works on production and manufacturing processes in a cleanroom environment, focusing on assembling, monitoring, and maintaining manufacturing equipment. In contrast, a Laboratory Technician typically conducts experiments, tests, and quality control procedures in a laboratory setting. Both roles require attention to detail and adherence to safety protocols, but their daily tasks and work environments differ significantly.

What are popular job titles related to Biotech Manufacturing Associate jobs in Indiana?

For Biotech Manufacturing Associate jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Biotech Manufacturing Associate jobs in Indiana look for?

The top searched job categories for Biotech Manufacturing Associate jobs in Indiana are:

What cities in Indiana are hiring for Biotech Manufacturing Associate jobs?

Cities in Indiana with the most Biotech Manufacturing Associate job openings:

Biotech Manufacturing Associate jobs near you
Infographic showing various Biotech Manufacturing Associate job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 70% Full Time, 26% Part Time, 1% Temporary, and 2% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $41,242 per year, or $19.8 per hour.

Associate Director, Quality Operations

Bloomington, IN • On-site

Simtra BioPharma Solutions
See more jobs at Simtra BioPharma Solutionsexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 18 days ago

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
The role:
The Associate Director Quality Operations is accountable for end-to-end Quality Operations and quality oversight for the Focus Factory. This role is a member of the Site Quality Leadership Team and a key member of the Focus Factory Leadership Team, reporting directly to the Quality Director. The incumbent owns quality performance for the Focus Factory and ensures that operations are executed in compliance with cGMP requirements, site procedures, corporate quality policies, applicable regulatory expectations, and client commitments. The role provides strategic and day-to-day leadership across Filling Quality Line Operations, Finishing /Inspection/Labeling/Packaging Quality Operations, Environmental Monitoring sampling/support, Warehouse and shipping quality oversight as applicable, Batch Record Review, Batch Disposition/Release, deviation/nonconformance management, and CAPA. The role ensures quality decisions are made with appropriate scientific, compliance, patient safety, and business risk considerations, while driving a culture of ownership, proactive escalation, continuous improvement, and right-first-time execution.
Role/Decision Scope:
  • Single point of Quality Operations accountability for the assigned Focus Factory, from manufacturing readiness through batch disposition and release.
  • Provides independent quality oversight and quality decision-making for routine operations, escalations, deviations, CAPA effectiveness, and inspection readiness.
  • Serves as an empowered Quality Leader and designee to the Quality Director for defined reviews, approvals, Quality Review Board endorsements, and escalation forums, as delegated by procedure or written delegation.
  • Partners with other cross Focus Factory quality functions, Manufacturing, Technical Services, Engineering, Supply Chain, QC, Regulatory, and Client Services to ensure quality, compliance, supply continuity, and patient safety are appropriately balanced and documented.

The responsibilities:
  • Establish clear quality priorities, resource plans, and coverage models to support 24/7 operations, including manufacturing floor support, real-time quality decision-making, and timely escalation of quality risks.
  • Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
  • Ensure the Focus Factory quality organization operates with strong ownership, accountability, and alignment to site quality strategy, operational goals, client commitments, and regulatory expectations.
  • Develops department annual budget and ensures spending within expected quarterly forecasts.
  • Assess workload, staffing, and skill mix to ensure the Quality Operations organization can provide effective oversight across all shifts and operating areas.
  • Participate in escalated client issue resolution (conference calls, client visits, audits).
  • Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.

Quality Oversight, Compliance, and Batch Disposition
  • Ensure quality oversight of aseptic filling operations, inspection, labeling and packaging operations, warehouse operations, finished product reserve sample inspection, finished product sampling, and product shipment activities as applicable.
  • Ensure timely and thorough QA review of batch records and associated documentation to meet internal release targets and contractual batch release commitments.
  • Verify that each batch disposition decision is scientifically justified, fully documented, compliant with procedures and regulations, and appropriately considers patient safety, product quality, SISPQ, and client/regulatory commitments.
  • Provide direction for review, approval, and escalation of deviations, nonconformance reports, investigations, root cause analyses, CAPAs, and effectiveness checks related to Focus Factory operations.
  • Identify, assess, and escalate emerging quality and compliance risks, including recurring deviations, quality system weaknesses, aseptic processing risks, sterility assurance risks, and trends that may affect batch disposition or supply.

Focus Factory Performance and Quality KPIs
  • Own Focus Factory quality and compliance performance metrics, including right-first-time performance, deviation aging, CAPA timeliness/effectiveness, batch release cycle time, inspection readiness, training compliance, and other site-defined KPIs.
  • Develop and use quality data, dashboards, and trend reports to drive performance management, proactive risk reduction, and decision-making at Focus Factory and Site Quality Leadership forums.
  • Lead or sponsor continuous improvement projects that strengthen quality culture, reduce repeat deviations, simplify execution, improve documentation quality, and support reliable batch release and supply performance.
  • Ensure robust management review and escalation of quality issues, including appropriate use of Quality Review Board and other governance forums.

People Leadership, Capability Building, and Culture
  • Interview, hire, coach, develop, and retain a high-performing Quality Operations team; set clear expectations, performance objectives, development plans, succession plans, and accountability measures.
  • Conduct performance reviews for direct reports and ensure performance management is fair, timely, evidence-based, and aligned with company expectations.
  • Create an environment of teamwork, inclusion, transparency, and constructive challenge where quality decisions are made with integrity and where safety, identity, strength, purity, and quality are reflected in the finished product.
  • Ensure training compliance and capability development for the QA team, including cGMP expectations, aseptic/sterility assurance concepts, deviation investigation, CAPA, batch record review, data integrity, and decision-making standards.
  • Model expected leadership behaviors, including prioritization, delegation, strategic thinking, cross-functional collaboration, proactive escalation, and continuous improvement.

Required qualifications:
  • Bachelor's degree required preference in a Life Science field; advanced degree preferred.
  • Minimum 8 years' experience in Quality or pharmaceutical industry experience.
  • Minimum 5 years' experience in a management role.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:
  • Must be able to qualify for entry into Class A/B aseptic facilities.
  • Must wear appropriate personal protective equipment as applicable.
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting for long hours but may involve walking or standing for periods of time.

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

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