Biopharma Manufacturing Associate II

Astellas Pharma

Westborough, MA

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JOB DETAILS

SALARY

$32.38–$46.25 Per Hour

SKILLS

Asepsis, Bioengineering, Biology, Biotech and Pharmaceutical, Cell Cultures, Chemical Engineering, Cleanroom, Clinical Support, Commissioning, Communication Skills, Compensation Management, Computer Skills, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Data Entry, Dental Insurance, Disease, Documentation, Equipment Validation, FDA Requirements, GMP (Good Manufacturing Practices), Healthcare, ISO (International Organization for Standardization), Immunology, Incentive Programs, International Business, Life Insurance, Lift/Move 25 Pounds, Manufacturing, Manufacturing Operations, Mathematics, Microsoft Excel, Microsoft Office, Microsoft Word, Multitasking, Oncology, Operational Support, Ophthalmology, Patient Care, Problem Solving Skills, Product Safety, Production Schedule, Quality Metrics, Record Keeping, Research & Development (R&D), Standard Operating Procedures (SOP), Startup, Urology, Validation Plan, Vehicle Fleets, Vision Plan, Willing to Travel, Women's Health

LOCATION

Westborough, MA

POSTED

1 day ago

Biopharma Manufacturing Associate II

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Biopharma Manufacturing Associate II will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Role and Responsibilities

+ Perform all manufacturing operations under cGMP/ISO requirements

+ Display understanding of Upstream process theory (e.g., cell thawing, passages, and harvesting) equipment operation, and aseptic processing

+ Assist with the installation, commissioning, and validation of equipment within single use facility

+ Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required

+ Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process

+ Maintain a high level of quality and compliance with regards to all aspects of manufacturing

+ Assist/write SOPs (standard operating procedures), batch records, and other GMP documentation

+ Display ability to identify and escalate potential GMP issues, as required

+ Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules

+ Assist in the evaluation and incorporation of new technologies

Required Qualifications

Education:

+ BS / BA in Chemical/ Biological Engineering or Life Sciences or Associate’s Degree in science or related field with 1+ years of industry experience.

Experience:

+ Experience in maintaining detailed records and ability to assist in document revisions

+ Experience in cell culture with excellent aseptic technique

+ Strong skill on biological laboratory math

+ Understanding of cGMPS as related to commercial and clinical operations

+ Strong communicator with ability to work effectively both independently and as part of a team • Developing problem-solving skills

+ Strong computer skills including MS Office (Word, Excel) and proven ability to establish and maintain effective working relationships with team members and managers

+ Models our Core Values: Be Bold, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

+ Will support and demonstrate quality standards to ensure data of highest quality and will be expected to perform other duties and/or special projects, as assigned

Preferred Qualifications

+ BioWork Certification or related type certifications are a plus along with technical understanding of a biotech manufacturing facility

+ Knowledge of upstream process and aseptic technique

+ Experience with single-use technologies

+ Understanding of FDA regulations

+ Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency

+ Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts

+ Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities

Location and Working Environment

+ This position is based in Westborough, MA and will require on-site work.

+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs.

+ This role supports the cleanroom. Gowning in to the cleanroom is expected.

+ This is a 100% on-site role working in a cGMP regulated manufacturing facility.

+ This roles requires to work in shifts – 4 x 10s, 12 hrs rotating, administrative or 2nd, depending on the business needs. Shift shall be assigned upon recruitment and are subject to change upon hire.

+ Assigned shift schedules is subject to change with or without notice based on critical operational needs.

+ Weekend work is often scheduled to support staffing and operational needs.

+ On occasion, this role may travel to other Astellas Biopharma Manufacturing facilities (0-5%)

What awaits you at Astellas?

+ Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

+ Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

+ Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

+ A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: _Innovation, Integrity_ and _Impact_ sit at the heart of what we do.

Behaviors: We come together as _‘One Astellas’_ , working with courage and a sense of _urgency_ . We are outcome focused and consistently take _accountability_ for our personal contribution.

Salary Range

$32.38-$46.25 (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 Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

About the Company

Astellas Pharma

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