... compendial verifications, experimental testing, and method validation protocols. • Follow written protocols, SOPs, and directions from other lab scientists and manager. • Lead lyophilization ...
... compendial verifications, experimental testing, and method validation protocols. • Follow written protocols, SOPs, and directions from other lab scientists and manager. • Lead lyophilization ...
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Analytical Chemist
Indianapolis, IN · On-site
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Analytical Chemist
Indianapolis, IN · On-site
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Quick apply
Company Description Eurofins Scientific is an international life sciences company, providing a ... Raw Materials Analytical testing could include: compendial testing, HPLC/UPLC, generic testing (e.g ...
Supervisor, QC Chemistry
$88K - $132K/yr
Essential Requirements: * BS or MS in Biology, Chemistry, Microbiology or other related science ... Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory ...
Supervisor, QC Chemistry
$88K - $132K/yr
Essential Requirements: * BS or MS in Biology, Chemistry, Microbiology or other related science ... Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory ...
Advisor/Senior Advisor Biophysical Characterization
$130.50K - $131K/yr
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid ... Familiarity with applicable ICH regulations and multi-compendial guidelines related to method ...
Advisor/Senior Advisor Biophysical Characterization
$130.50K - $131K/yr
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid ... Familiarity with applicable ICH regulations and multi-compendial guidelines related to method ...
Advisor/Senior Advisor Biophysical Characterization
Indianapolis, IN · On-site
$130.50K - $131K/yr
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid ... Familiarity with applicable ICH regulations and multi-compendial guidelines related to method ...
Advisor/Senior Advisor Biophysical Characterization
Indianapolis, IN · On-site
$130.50K - $131K/yr
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid ... Familiarity with applicable ICH regulations and multi-compendial guidelines related to method ...
Compendial Scientist information
What are the key skills and qualifications needed to thrive as a Compendial Scientist, and why are they important?
What are some common challenges faced by Compendial Scientists when ensuring compliance with evolving pharmacopeial standards?
What are Compendial Scientists?
What is the difference between Compendial Scientist vs Quality Control Analyst?
| Aspect | Compendial Scientist | Quality Control Analyst |
|---|---|---|
| Required credentials | Bachelor's degree in life sciences, certifications in GMP/GLP | Bachelor's degree in sciences, certifications in GMP/GLP |
| Work environment | Laboratories, regulatory agencies, pharmaceutical companies | Laboratories, pharmaceutical manufacturing facilities |
| Employer and industry usage | Used in regulatory compliance, ensuring products meet pharmacopeial standards | Used in testing and analyzing raw materials and finished products |
Compendial Scientists focus on ensuring products meet pharmacopeial standards and regulations, often working on documentation and compliance. Quality Control Analysts primarily perform testing and analysis of samples to verify product quality. Both roles require similar credentials and work environments, but their core responsibilities differ in scope and focus.
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 16 days ago
Job description
Why join Team Singota?
We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that's not just efficient, but also passionate, dedicated, and fun to work with.
Job Title: Pharmaceutical Scientist 2- Analytical Development
Department: Quality Control/Development
Reports to: Laboratory Manager/Senior Scientist
Location: Bloomington, IN (Onsite)
Position Type: Full-time, Exempt, 40 hr/wk
General Description including Skills and Physical Activity Requirements:
The role of the Pharmaceutical Scientist 2 - Analytical Development includes the following key functions carried out in according to the company vision, mission, standards, goals, objectives, and strategic direction:
• Actively participates and can lead Development projects for the QC/DEV department including process and analytical development activities.
• Collaboratively supports the Quality Control function with respect to raw material, in-process, release, and stability testing.
• Mentor Scientists and invested in continuing education.
1. Actively participates and can lead Development Projects for the QC/DEV department including process and analytical development activities.
• Operate various lab instruments and equipment as an SME including (but not limited to): Karl Fisher, pH, HPLC, FTIR, UV-VIS, DSC, TOC, Lab-ware washers, Autoclave, Laminar Flow Hoods, Bio-Hazard Hood, Microbalances, and other diverse lab equipment and various wet chemistry techniques.
• Lead method transfer activities by authoring, and executing protocols for compendial verifications, experimental testing, and method validation protocols.
• Follow written protocols, SOPs, and directions from other lab scientists and manager.
• Lead lyophilization development studies using (but not limited to) DSC, FDM, small-scale lyophilization, XRD, and supporting wet chemistry methods.
• Follow company documentation SOPs to record and summarize laboratory findings in formal analytical methods reports.
• Communicate project status to Sr. Pharmaceutical Scientists, QC/DEV Management, and Project Management personnel.
• Monitor usage of laboratory supplies and chemicals, including glassware, equipment, materials, client drug substance/product, and excipients, and assist with material purchases.
• General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
• Technical writing ability to be the lead author on lab reports, SOPs, PM/SC documentation.
• Analytical Development client representative for QC/DEV
2. Collaboratively supports the Quality Control function with respect to raw material, in-process, release, and stability testing.
• Perform quality control analyses on a variety of equipment following formal written documentation, including SOPs, client methods, and compendial requirements.
• Review experimental data, analytical data, and laboratory reports for accuracy.
• Record and summarize work conducted and findings according to company documentation SOPs.
• Comply with company and laboratory quality and safety management systems including requirements for documentation, training, system use, SOPs, and processes.
• Primary analytical liaison between PPD and the laboratory for testing PPD study samples
3. Mentor Scientists and invested in continuing education.
• Mentor associate scientists on diverse analytical methods applicable to parenteral product development, including HPLC, Karl Fischer, XRD, CE, UV Vis, and various wet chemistry techniques.
• Support in the training of new QC/DEV staff to increase team strength and flexibility.
• Promotes a highly professional working environment within the company.
• Engage in effective teamwork between operating groups to lead the company towards meeting its goals and objectives.
Requirements
Characteristics required include:
1. Strong interest and commitment to exceptional customer service and teamwork.
2. Highly motivated- independent and self-directed work ethic; good judgment and strong decision-making skills; driven to continuously improve.
3. Excellent interpersonal skills-respected by others with an ability to lead and influence; positive and action-oriented; high degree of personal integrity and accountability; ability to communicate effectively and professionally across various audiences and organizational levels.
4. Positive attitude and good judgment - reflective of company values.
5. Technical knowledge base.
6. Excellent time management, organization skills, and ability to manage multiple priorities with high attention to detail in a fast-paced, deadline driven, work environment.
7. Excellent communication and presentation skills - oral and written.
8. Ability to travel to client sites and trade shows.
9. Ability to problem solve and resolve issues and conflicts.
Skills and Physical Activity Requirements:
1. Excellent skills in MS Word, Excel, Outlook and the ability to effectively learn other computer programs.
2. Familiarity with and the ability to quickly learn operation of standard laboratory instruments with normal training and access to instrument manuals.
3. Ability to read computer displays.
4. Ability to work in both office and laboratory environments requiring sitting and standing.
5. Manual dexterity and eyesight commensurate with wet chemistry analytical techniques.
6. Must wear personal protective equipment including protective gloves, lab coats, and safety glasses or face shield at times.
Education and Work Experience Requirements:
• BS in Chemistry / related discipline
• Has experience and training in a GMP, GLP, or other regulated organization
• Minimum of 5 years of relevant formulation, analytical testing, and/or academic experience
• Minimum of 5 years pharmaceutical and/or life science experience preferred, including experience in a contract service organization
Benefits
- Dental insurance - effective day one of employment
- Health insurance - effective day one of employment
- Vision insurance - effective day one of employment
- Health savings account
- Life & AD&D insurance
- Short & long term disability
- Paid time off & holidays
- Employee Assistance Program
- Tuition assistance
- 401(k) with company match
Singota Solutions is an Equal Opportunity Employer
About Singota Solutions
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Bloomington, IN, US
Year founded
2006