Simtra BioPharma Solutions · 1 day ago
Research Associate II - Analytical
Bloomington, IN
Full-time
Onsite
Entry, Mid Level
2+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies. The Research Associate II role is responsible for independently managing analytical method development, validation and transfer projects for clients while supporting formulation development projects.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Independently plan and execute a series of design and/or technical projects (small and large molecules) that may or may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines from early pre-formulation/formulation development to technical transfer of established formulations and processes in manufacturing operations
Lead the evaluation, selection, and adaptation of new technologies and techniques to accomplish business objectives, such as quality and cycle-time
May provide training to other employees within the department or plant
Routinely provide advice and assistance to team members regarding unique problems
Provide responsive customer service to external customers and internal project managers
Support department Enterprise Management System (EMS) and Quality Assurance initiatives
Devise new approaches to complex formulation and process development problems through adaptations and modifications of standard technical principles and incorporate new methods and technologies for improving existing or new products/processes
Maintain current knowledge of relevant quality and regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
Develop an in-depth knowledge and understanding of Good Manufacturing Practices (GMP) and related regulations and guidance
Act as an Analytical Instrument Subject Matter Expert and support instrument validations and/or periodic review validations
Contribute to technical feasibility analysis of complex research and analytical method concepts
Evaluate results relative to product requirements, definitions and/or program goals
Qualification
Required
BS degree in Chemistry, Biochemistry, Pharmaceutical Science or related scientific discipline required
2+ years of laboratory experience (MS or PhD in Chemistry, Biochemistry, Pharmaceutical Science, or related scientific discipline in lieu of laboratory experience)
Expertise in fundamentals of freeze-drying, including characterization of formulations intended to be freeze-dried and characterization of lyophilized solids
Experience in chromatography, spectroscopy and other analytical methods (i.e. HPLC, CE, ELISA, UV, FTIR, etc.)
Good scientific technique in a corporate laboratory setting
Strong written and oral communication skills with the ability to interact with external and internal stakeholders
Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
Experience with following software and/or programs: Minitab, JMP, or Python
Knowledge and/or ability to use Enterprise software (i.e., JDE, Veeva, Trackwise, etc.)
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability 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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase