Process Engineer, Upstream Process Characterization & Commercialization

We are seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector this role you will contribute to late-stage development process characterization PPQ readiness BLAenabling studies and technology transfer to internal and external manufacturing sites.

This position focuses specifically on upstream unit operations including shake flask and bioreactor-based cell culture transient transfection cell expansion harvest operations and scaleup across development and commercial platforms (including Amber systems).

The ideal candidate has strong handson experience in upstream viral vector manufacturing transient transfection-based processes and can provide onthefloor technical leadership during engineering PPQ and commercial campaigns.

Key Responsibilities

Upstream Process Characterization & Validation

• Design execute and support upstream process characterization studies (DOE multivariate studies scaledown models and scaleup assessments).

• Develop and execute characterization strategies to define CPPCQA linkages for upstream unit operations.

• Perform data analysis technical report authorship and presentation of study outcomes to crossfunctional teams and governance forums.

• Support development and refinement of control strategies for upstream processes including raw materials transfection reagents cell banks and process parameters.

• Conduct batch record review deviation assessment and data trending to ensure robustness of upstream manufacturing processes.

• Apply AIenabled tools and digital analytics to accelerate data review trend analysis batch record evaluation and process understanding.

PPQ Tech Transfer & Manufacturing Readiness

• Contribute to PPQ planning readiness execution and documentation for upstream processes.

• Support technology transfer of upstream processes to internal manufacturing sites and CDMOs including fitforpurpose assessments and scale translation.

• Provide onthefloor technical support during scaleup engineering runs PPQ batches and commercial manufacturing campaigns (including offshift support when required).

• Support raw material risk assessments comparability studies and process risk evaluations across facilities and platforms.

Regulatory Support

• Contribute to authoring and review of CMC documentation including upstream process descriptions characterization summaries PPQ protocols and reports and control strategy elements.

• Support preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing.

CrossFunctional Collaboration

• Work closely with downstream analytical sciences quality regulatory and manufacturing teams to ensure endtoend process alignment.

• Represent upstream characterization activities in technical meetings reviews and governance discussions.

• Support lifecycle management postapproval changes and continuous improvement initiatives for upstream processes.

Required Qualifications

• Ph.D. in Chemical Engineering Biochemical Engineering Biotechnology or related field with 1 years of industry experience; OR M.S. with 4 years; OR B.S. with 5 years of handson industry experience.

• Handson experience with upstream viral vector manufacturing including transient transfectionbased processes.

• Experience with shake flask benchscale pilotscale and commercial bioreactor systems; experience with Amber systems strongly preferred.

• Experience with latestage development process characterization and PPQ principles for upstream processes.

• Demonstrated proficiency in applying AI tools and digital solutions to data analysis documentation and workflow automation.

• Experience working in GMP environments including batch record execution or review deviations and investigations.

• Strong technical writing data analysis and problemsolving skills.

Preferred Qualifications

• Experience supporting latestage viral vector programs (lentiviral AAV adenoviral VLPs).

• Experience designing and executing DOE and multivariate data analysis for upstream processes.

• Experience contributing to BLA/MAA submissions or regulatory interactions.

• Knowledge of control strategy development and risk assessment tools (e.g. FMEA).

• Formal training or demonstrated application of digitalization automation or AIenabled tools in bioprocess development.

Key Competencies

• Strong experimental design and execution skills.

• Excellent crossfunctional communication and collaboration.

• Ability to operate effectively in fastpaced latestage development environments.

• Scientific curiosity ownership mindset and willingness to support manufacturing operations.

The annual base pay for this position ranges from $76308.00 - $114462.00. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.