Job Description

We have an exciting opportunity for a Assoc. Process Engineer Technical Operations Drug Substance to join our growing team.

At our company we aspire to be the premier research-intensive biopharmaceutical company using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably receiving technology transfers from commercialization sites and fast-following into production with a focus on quality safety and operational excellence.

At our site youll be part of a team committed to creating a safe environmentally responsible and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S. and we want team members who are excited to grow their skills help improve how we operate and contribute to a site positioned for future growth.

The successful candidate will provide technical support for the facility design commissioning qualification through technology transfer validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

In this role you will work as part of a cross-functional team initially supporting the capital project and transitioning to technology transfer and commercial manufacturing while building technical expertise and contributing to operational excellence.

Key Responsibilities

Technical & Process Support

• Support the Capital Project Team contributing to design commissioning qualification and startup readiness
• Knowledge and subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.

• Take ownership of assigned process equipment and manufacturing processes
• Support technology transfer and validation activities (e.g. pre-PPQ PPQ)
• Analyse process data to support performance monitoring troubleshooting and improvement
• Provide on-the-floor technical support during manufacturing campaigns

Technology Transfer & Commercialisation

• Support execution of technology transfers for new products and processes into the facility
• Partner with Commercialization and external sites to ensure effective process knowledge transfer
• Contribute to process fit assessments scale-up readiness and manufacturability evaluations
• Support development and review of batch documentation and process instructions
• Assist in integration of new technologies into manufacturing operations

Process Optimisation & Operational Excellence

• Identify and implement improvements in process robustness product quality and plant performance
• The successful candidate will have an aptitude for technical problem solving with a background in solving technical issues to obtain a positive outcome.
• Contribute to cleaning and turnaround optimisation activities
• Assist in deviation investigations root cause analysis and implementation of CAPAs
• Monitor process performance yields and cycle times to identify improvement opportunities

Compliance & Documentation

• Ensure all activities are conducted in compliance with cGMP safety and environmental standards
• participation in campaign preparation safety and environmental reviews batch sheet reviews
• Support campaign preparation execution and post-campaign review activities
• Support batch record generation review and ongoing optimisation
• Assist in regulatory and inspection readiness activities
• Ensure accurate documentation of process knowledge investigations and improvements

Cross-functional Collaboration

• Work closely with Manufacturing Quality Engineering Supply Chain and R&D teams
• Provide technical input into projects process changes and ongoing operations
• The candidate will have excellent communication skills with an aptitude of imparting and guiding complex projects across boundaries and an ability to convey and link with people at all levels of the organisation in a helpful compliant manner.

Qualifications

To excel in this role you will have:

• Bachelors Degree in Chemical or Process Engineering or related discipline

• Typically 14 years experience in API manufacturing process development or related pharmaceutical environment
• Exposure to API processing operations and scale-up
• Understanding of cGMP manufacturing and regulatory expectations

• Experience in one or more of:
  • Process support or development
  • Technology transfer
  • Manufacturing operations

Key Skills:

• Strong analytical and problem-solving capability
• Ability to analyse data and make sound technical decisions
• Effective communication and collaboration across cross-functional teams
• Ability to manage priorities meet deadlines and deliver quality outcomes
• Proactive self-driven approach to continuous improvement

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the worlds most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive high-performing environment.

So if you are ready to:

• Support delivery of new Drug Substance manufacturing capability
• Develop your expertise in API processing and commercialisation
• Contribute to a high-impact technology-driven manufacturing environment

we encourage you to apply.

#ELKVACOE

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Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

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We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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