... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... Review and analyze operational data to identify trends, recurring issues, and opportunities to ...
... data science teams. With regular access to coaching and mentorship from top Lilly leaders, upon ... biotech, drug development, investment banking. * Unique and ambitious business leadership
... data science teams. With regular access to coaching and mentorship from top Lilly leaders, upon ... biotech, drug development, investment banking. * Unique and ambitious business leadership
Biorepository Sample Management Technician
Franklin, IN ยท On-site
$23/hr
... a biotechnology and life science leader. Location: Onsite in Franklin, IN Duration: Contract to ... Ability to prioritize multiple tasks while maintaining data accuracy and compliance. Preferred
Biorepository Sample Management Technician
Franklin, IN ยท On-site
$23/hr
... a biotechnology and life science leader. Location: Onsite in Franklin, IN Duration: Contract to ... Ability to prioritize multiple tasks while maintaining data accuracy and compliance. Preferred
... a biotechnology and life science leader. Location: Onsite in Franklin, IN Duration: Contract to ... Ability to prioritize multiple tasks while maintaining data accuracy and compliance. Preferred
Quick apply
... a biotechnology and life science leader. Location: Onsite in Franklin, IN Duration: Contract to ... Ability to prioritize multiple tasks while maintaining data accuracy and compliance. Preferred
Solution Manager Clinical Tech Data Management
$124K - $182K/yr
... pharmaceutical, biotech, or healthcare, including validation and change control processes ... Preferred Qualifications Bachelor's degree in Computer Science, Engineering, Life Sciences ...
Solution Manager Clinical Tech Data Management
$124K - $182K/yr
... pharmaceutical, biotech, or healthcare, including validation and change control processes ... Preferred Qualifications Bachelor's degree in Computer Science, Engineering, Life Sciences ...
Bachelor's degree in Computer Science, Engineering, Life Sciences, Business, ora relatedfield ... pharmaceutical, biotech, or healthcare, including validation and change control processes.
Bachelor's degree in Computer Science, Engineering, Life Sciences, Business, ora relatedfield ... pharmaceutical, biotech, or healthcare, including validation and change control processes.
Solution Manager Clinical Tech Data Management
$124K - $182K/yr
... pharmaceutical, biotech, or healthcare, including validation and change control processes ... Preferred Qualifications Bachelor's degree in Computer Science, Engineering, Life Sciences ...
Solution Manager Clinical Tech Data Management
$124K - $182K/yr
... pharmaceutical, biotech, or healthcare, including validation and change control processes ... Preferred Qualifications Bachelor's degree in Computer Science, Engineering, Life Sciences ...
Bachelor's degree in Computer Science, Engineering, Life Sciences, Business, or a related field ... pharmaceutical, biotech, or healthcare, including validation and change control processes.
Bachelor's degree in Computer Science, Engineering, Life Sciences, Business, or a related field ... pharmaceutical, biotech, or healthcare, including validation and change control processes.
Experience working within life sciences, healthcare, pharmaceutical, medical device, biotech, healt ... Strong working knowledge of data structures and database design * Knowledge of how to use ...
Experience working within life sciences, healthcare, pharmaceutical, medical device, biotech, healt ... Strong working knowledge of data structures and database design * Knowledge of how to use ...
Promote scientific excellence and data integrity while providing mentorship and technical guidance ... biotechnology, or animal health research environment. * Top Skills: Demonstrated expertise in ...
Promote scientific excellence and data integrity while providing mentorship and technical guidance ... biotechnology, or animal health research environment. * Top Skills: Demonstrated expertise in ...
Data Reviewer, Quality Control Microbiology
Indianapolis, IN ยท On-site
$31.07 - $37.64/hr
... biotech with the global expertise and resources of a leading innovator in oncology. Our mission is ... From day one, expect to make an immediate impact-on our science, on our teams, and most importantly ...
Posted today
Data Reviewer, Quality Control Microbiology
Indianapolis, IN ยท On-site
$31.07 - $37.64/hr
... biotech with the global expertise and resources of a leading innovator in oncology. Our mission is ... From day one, expect to make an immediate impact-on our science, on our teams, and most importantly ...
Posted today
We are a team of strategists, data scientists, operators, creatives, designers, engineers, and ... biotech or medical device clients and cross-functional implementation teams to identify and ...
We are a team of strategists, data scientists, operators, creatives, designers, engineers, and ... biotech or medical device clients and cross-functional implementation teams to identify and ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
With state-of-the-art facilities and close ties to Indianapolis' thriving healthcare, biotech, and ... large, complex data sets. Overall, IU Indianapolis research contributes significantly to the ...
... science and product performance, providing scientific leadership to distinguish analytical ... Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls ...
Quick apply
... science and product performance, providing scientific leadership to distinguish analytical ... Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls ...
Senior Scientist, Quality CMC
Portage, IN ยท On-site
... science and product performance, providing scientific leadership to distinguish analytical ... Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls ...
Senior Scientist, Quality CMC
Portage, IN ยท On-site
... science and product performance, providing scientific leadership to distinguish analytical ... Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls ...
Freelance Biotech Data Science information
What is the difference between Freelance Biotech Data Science vs Biotech Data Analyst?
| Aspect | Freelance Biotech Data Science | Biotech Data Analyst |
|---|---|---|
| Credentials | Typically requires advanced degrees (Master's/PhD) in data science, bioinformatics, or related fields | Often requires a bachelor's or master's degree in biology, bioinformatics, or related areas |
| Work Environment | Independent, project-based, remote or on-site consulting | Full-time or part-time employment within biotech companies or labs |
| Employer & Industry Usage | Freelance consultants working with biotech firms, research institutions, or startups | Biotech companies, research labs, pharmaceutical firms |
Freelance Biotech Data Scientists focus on complex data modeling, machine learning, and bioinformatics projects independently, while Biotech Data Analysts typically handle data interpretation, reporting, and visualization within organizations. The freelance role offers flexibility and diverse projects, whereas the analyst role provides a stable, team-based environment.
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 7 days ago
Job description
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.
This role:
The Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.
Schedule: Friday-Sunday 7:00am-7:30pm
The responsibilities:
- Lead and execute investigations for deviations, including defining scope, applying structured problem-solving methods, and documenting results in compliance with cGMP standards.
- Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
- Investigate the root cause(s) of the issue and document the investigation results
- Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
- Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
- Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
- Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
- Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
- Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
- Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation
- Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations
Required qualifications:
- BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
- 2+ years technical writing experience, preferably in pharmaceutical industry
- Must have knowledge of GMPs and worldwide regulatory agency guidelines.
- Knowledge of applicable CAPA procedures, specifications, regulations and standards
- Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
- Goal-setting, prioritize, organization, attention to detail, and time management skills
- Critical & creative thinking and problem-solving skills
- Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
- Strong oral and written communication skills
- Ability to demonstrate strong leadership skills
- Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
- Ability to utilize enterprise software systems (Veeva)
Physical / safety requirements:
- Duties will require overtime work, including nights and weekends on occasion
- Ability to gown in C/D gowning area
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/