Process Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose and Scope:

The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC.

Essential Job Responsibilities:

• Provide process engineering, design, and on-going improvements for drug substance manufacturing processes

• Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities

• Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization

• Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners

• Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and

• Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation

• Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements

• Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports

• Support/lead tech transfer, equipment commissioning, training, and validation activities

• Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing

• Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems

• Support process deviation investigations, root cause analysis, and CAPAs

• Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction

• Will support and demonstrate data integrity standards to ensure data of highest quality

Qualifications

Required:

• MS in Engineering or Life Sciences, entry level, or BS with 2 years of relevant technical experience.

• Sound technical knowledge of upstream or downstream bioprocessing with a background in biologic or ATMP process development, technical transfer, and/or manufacturing

• Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers

• Ability to think critically, and demonstrated troubleshooting and problem-solving skills

• Demonstrated experience with interpreting complex data sets

• Effective scientific communication skills, including technical writing and presentation of technical content to diverse audiences

• Capable of working independently with minimal supervision

• Desire to work within a fast-paced environment under challenging timelines

• Attention to detail supported by good time management and organizational skills

• Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio)

Preferred:

• Experience in gene therapy and/or monoclonal antibody manufacturing, scale-up/scale-down, and tech transfer

• Understanding of industry expectations with respect to phase appropriate requirements while advancing products from pre-clinical to commercial state

• Experience with statistical analysis and associated software (e.g., JMP)

• Experience with single-use equipment and systems

• Knowledge of cGMPs and good documentation practices (GDP)

• Experience with process equipment and facility design engineering such as hydraulic calculations, equipment sizing, process simulations, Heat and Material Balances (H&MB), Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and User Requirement Specification (URS) development

• Experience with process validation and lifecycle management

• Experience supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ

Working Environment:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

• As assigned, this position may be required to work during non-traditional work hours to support critical business operations

• This is an on-site role working in a cGMP regulated manufacturing facility with some hybrid flexibility

• On occasion, this role may travel to other Astellas sites and/or vendors (0-5%)

Salary Range : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits :

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Company fleet vehicle for eligible positions

• Referral bonus program

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Category Sanford TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans