Manufacturing Science and Technology (MSAT)

Simtrabps; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Education Assistance Program

Paid Time Off

Job summary

Simtrabps is looking for a Tech Transfer Senior Associate to manage technical onboarding and process development for new drug projects. This role requires 7+ years of experience in pharmaceutical manufacturing and includes responsibilities like leading cross-functional teams in development activities and conducting regulatory audits.

The position is 100% onsite at the Bloomington facility, emphasizing process validation and documentation management. Strong candidates will have expertise in aseptic processing and proficiency in Microsoft Office Suite.

Qualifications

• 7+ years of pharmaceutical manufacturing experience.
• 3+ years of Technical Transfer/Process Development experience.
• In-depth knowledge of systems and equipment.

Responsibilities

• Lead onboarding and process development activities.
• Provide technical support on the manufacturing floor.
• Manage Change Control and documentation processes.

Skills

Pharmaceutical manufacturing experience

Technical Transfer/Process Development experience

Aseptic processing expertise

Microsoft Office Suite proficiency

Education

BS degree in science or engineering

Tools

JDE

BPLM

Minitab

Trackwise

Job description

Job Overview

The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate 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 to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

Responsibilities

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross‑functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal (Technical Transfer Plan, Process Development studies, 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
• Provide technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Lead process improvement activities
• Independently conduct Non‑Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participate in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participate independently in client calls and on‑site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in‑depth SME courses on pharmaceutical industry topics
• Mentor new hires in Technical Services Department and helps with training and on‑boarding

Required Qualifications

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In‑depth knowledge of systems and equipment – including scales, mixing systems, mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency – Word, Excel, Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / Safety Requirements

• Duties will require overtime work on occasion, including nights and weekends
• 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)

Benefits

In return, you’ll be eligible for the following benefits:

• Day One 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
• Additional Benefits
  • 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

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.

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