Manager, Drug Product Manufacturing

Ultragenyx; Bedford (MA); On-site; USD 123,000 - 152,000; Full time

Benefits offered by this job

Annual bonus

Equity incentives

Generous vacation time

Employee stock purchase plans

Fitness reimbursement

Job summary

Ultragenyx is seeking a Drug Product Manufacturing Manager in Bedford, MA to lead aseptic filling operations and visual inspection for our Gene Therapy Manufacturing Facility. The role involves supervising assembly of manufacturing associates and ensuring GMP compliance.

You will drive training, cGMP adherence, and continuous improvement in drug product processes while coordinating with cross-functional teams.

Qualifications

• Hands-on experience in aseptic drug product filling operations.
• Experience with isolator and/or RABS technology required.
• 8 years’ experience in pharmaceutical manufacturing; supervisory experience preferred.
• Strong collaboration and communication skills.

Responsibilities

• Plans and supervises daily execution of tasks to support production plan and supervises completion of work.
• Ensure qualification of operators to support cGMP manufacturing of pharmaceutical products.
• Supports quality investigations, continuous improvement, and maintenance activities in the manufacturing area.
• Generates and approves SOPs, batch records, and protocols for equipment and processes.
• Ensure compliance with environmental health and safety requirements.

Skills

Hands-on aseptic operations

Supervisory experience

Team collaboration

Communication skills

Education

BS in Engineering or scientific discipline

Tools

Isolator technology

RABS technology

Job description

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work.Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally andpersonally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Manager Manufacturing, Drug Product will report to the Director of DP Manufacturing. The Drug Product Manufacturing Manager will support the operations of Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, MA. The Drug Product Manufacturing Manager will be a hands‑on manufacturing SME for drug product filling operations and visual inspection. You will support continuous commercial manufacturing for Drug Product operations . You will be responsible for the training and supervision of manufacturing Associates for the aseptic filling area, and visual inspection and labeling /bulk pack operations.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Plans and supervises daily execution of tasks to support published production plan and supervises completion of work
• Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical products
• Supports quality investigations, continuous improvement efforts and engineering/maintenance/quality control/quality operations activities as they directly impact the functionality of the manufacturing area
• Ensure maintenance and upkeep of the facility and process employed within the area of responsibility
• Generates / Drives / Approves new/revised SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Drug Product manufacturing area
• Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements.
• You will be a manufacturing SME for drug product filling operations, including vial filling and isolator system and visual inspection.
• Ensures robust and timely communication of defined operational / planning activities associated with the execution of daily production

Requirements:

• BS in Engineering, Scientific Discipline preferred or Business equivalent experience
• Must have hands‑on experience in aseptic operations for filling of a parenteral is required.
• Experience with isolator and/or RABS technology is required.
• 8 years’ experience preferably in pharmaceutical manufacturing or other regulated industry
• Minimum of 2 years of supervisory experience preferred
• Experience training and developing team members is preferred
• Strong collaboration, team‑working skills and communication skills
• Independently motivated and detail‑oriented with good problem‑solving ability

Physical Demand Requirements (On the floor support/supervision may be occasionally required) :

Manufacturing: Drug Product

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Must complete and pass a vision exam to verify clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors with or without correction.
• Only if performing Visual Inspection processes

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range

$123,100 - $152,000 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Long term incentive and Employee stock purchase plans or equivalent offerings

Fitness reimbursement

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [e-mail].