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What are the key skills and qualifications needed to thrive as a Biotechnology Industry Professional, and why are they important?

To thrive as a professional in a biotechnology company, you generally need a background in life sciences, chemistry, or engineering, often supported by a relevant degree or advanced studies. Familiarity with laboratory techniques, data analysis software, and regulatory compliance systems like GLP, GMP, or FDA guidelines is typical. Strong problem-solving abilities, teamwork, and effective communication skills help individuals excel in cross-functional biotech environments. These competencies enable professionals to drive innovation, ensure product quality, and navigate regulatory landscapes essential for the success of biotech organizations.

What are biotech companies?

Biotech companies are organizations that use biological processes, organisms, or systems to develop products and technologies that improve human life. These companies often focus on areas such as healthcare, agriculture, environmental science, and industrial applications. They may develop new medicines, genetically modified crops, diagnostic tools, or sustainable manufacturing processes. Biotech companies play a vital role in innovation and often collaborate with research institutions and government agencies.

What is the difference between Biotech Companies In vs Biotech Research Associates?

AspectBiotech Companies InBiotech Research Associates
CredentialsBachelor's or Master's in Life SciencesBachelor's or Master's in Life Sciences
Work EnvironmentCorporate labs, R&D departmentsResearch labs, clinical settings
Employer & Industry UsageBiotech firms, pharmaceutical companiesResearch institutions, biotech firms
Common Search & ComparisonYesYes

Biotech Companies In typically refers to employment within biotech firms' corporate environments, focusing on product development and commercialization. Biotech Research Associates usually work in research labs or clinical settings, concentrating on experimental and scientific research. Both roles require similar educational backgrounds but differ in work focus and environment.

What are some common challenges faced by employees working in biotech companies?

Employees in biotech companies often face challenges such as rapidly evolving technology, tight project deadlines, and strict regulatory compliance requirements. Collaboration across multidisciplinary teams—including scientists, engineers, and regulatory professionals—is crucial, which can sometimes lead to communication hurdles. Additionally, adapting to shifting project priorities and maintaining flexibility in a dynamic environment are important for success. Despite these challenges, the work is rewarding and offers significant opportunities for professional growth and impact.
What are popular job titles related to Biotech Companies In jobs in Indiana? For Biotech Companies In jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Biotech Companies In jobs in Indiana look for? The top searched job categories for Biotech Companies In jobs in Indiana are:
What cities in Indiana are hiring for Biotech Companies In jobs? Cities in Indiana with the most Biotech Companies In job openings:
Biotech Companies In jobs near you

Principal Manufacturing Science and Technology (MSAT) Representative

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Posted 24 days ago

Job description

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
The Principal Manufacturing Science and Technology (MSAT) Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.
What you'll be doing:
  • Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
    • Serve as the lead technical expert among a cross functional team
    • Lead the cross functional team through technical activities, development studies and PPQ batches
    • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
    • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
    • Lead during hand-off to the commercial team following PPQ batches
  • Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
  • Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
  • Change Control Management (CCM) owner and impact assessment
  • Ownership of fill volume dosing qualifications (FVOQ)
  • Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
  • Participates in new project reviews to determine acceptable fit
  • Reviews Master Batch Records of junior colleagues and provides guidance
  • Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
  • Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
  • SOP owner & process SME
  • Perform filter troubleshooting
  • Develops and presents in-depth SME courses on pharmaceutical industry topics
  • Mentors new hires in Technical Services and helps with training and on-boarding

What you'll bring:
  • BS degree required (preferably in a science or engineering related field
  • 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
  • Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
  • Experience in aseptic processing, sterile filtration, and process validation
  • MS Office Suite advanced proficiency
  • Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:
  • Require overtime work on occasion, 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
  • Must be able to qualify for Grade A/B area gowning
  • Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1
Equal Employment Opportunity
Simtra is 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

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