Senior Technical Transfer Associate

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled 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, 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 Senior Technical Transfer Associate 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.The responsibilities:Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studiesLead the cross-functional team through technical activities, development studies and PPQ batchesCreate technical transfer documents supporting this goal [Technical 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 developmentLead during hand-off to the commercial team following PPQ batchesProvides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturingLeads process improvement activitiesIndependently 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 assessmentOwnership of Fill Volume Dosing Qualification (FVOQ) documentationCritical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirementsParticipates in new project reviews to determine acceptable fitReviews Master Batch Records of junior colleagues and provides guidanceIndependently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAsParticipates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutionsStandard Operating Procedures (SOP) owner & process subject matter expert (SME)Perform filter troubleshootingDevelop and present in-depth SME courses on pharmaceutical industry topicsMentors new hires in Technical Services Department and helps with training and on-boardingRequired qualifications:BS degree, preferably in a science or engineering related field7+ years pharmaceutical manufacturing experience3+ years of applicable Technical Transfer/Process Development experienceIn-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 trendsExpertise in aseptic processing, sterile filtration, and Process ValidationMicrosoft Office Suite advanced proficiency Word, Excel, and OutlookKnowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)Physical / safety requirements:Duties will require overtime work on occasion, including nights and weekendsPosition requires sitting for long hours but may involve walking or standing for periods of timeMust be able to qualify for Grade A/B area gowningMust be able to wear applicable personal protective equipment (PPE)In return, you’ll be eligible for [1]: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life InsuranceShort and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramAdditional BenefitsVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union[1] Current benefit offerings are in effect through 12/31/24DisclaimerThis 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 OpportunitySimtra 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.EEO is the Law EEO is the law - Poster SupplementPay Transparency PolicyData PrivacyTo 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