Manager, Drug Product Manufacturing

Ultragenyx Pharmaceutical; Bedford (MA); Vor Ort; USD 123.000 - 152.000; Vollzeit

Benefits dieser Stelle

Vacation time

Volunteer days

Stock purchase plan

Wellbeing benefits

Fitness reimbursement

Tuition sponsorship

Professional development

Zusammenfassung

Ultragenyx Pharmaceutical in Bedford, MA seeks a Drug Product Manufacturing Manager to oversee aseptic filling operations and visual inspection. You will train and supervise manufacturing associates, ensure cGMP compliance, and support continuous manufacturing at the Gene Therapy facility.

This hands-on role requires a BS in engineering or related field, 8 years pharma experience, and experience with isolator or RABS technology.

Qualifikationen

• BS in Engineering, Scientific Discipline preferred or Business equivalent experience.
• 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.

Aufgaben

• 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

Kenntnisse

Aseptic operations

Supervisory experience

Isolator/RABS

Team collaboration

Problem solving

Ausbildung

BS in Engineering or Scientific Discipline

Business equivalent experience

Jobbeschreibung

Why Join Us?

Be a hero for our rare disease patients

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 and personally, 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)

• 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

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
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans

* 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].

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