Catalent Pharma Solutions

Position Summary

Lead – Biomanufacturing

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The Lead – Biomanufacturing will act as the functional lead for manufacturing projects in partnership with Process Development (PD), Manufacturing Sciences and Technology (MS&T), and Quality.

Work Days: Sunday to Wednesday

Work Hours: 06:00AM to 4PM (Can be flexible from 06:00 to 08:00 start). Ability to work scheduled shift and other off-shift coverage as required.

The Role:

• Lead Rapid Response Team as deviations occur, documenting critical information to determine true root cause.

•Oversee the timely review of logbooks as needed to ensure data complies with cGMP expectations; Track/monitor and provide timely, accurate information regarding status of open investigations.

• Lead initiatives to improve process compliance culture, including on-going cGMP understanding and application, including self-audit and CAPA programs.

• Actively engage in internal audits and recommend actions for closure of applicable findings; Lead Inspection Readiness activities and teams.

• Identify and correct training issues, instruction problems, or new educational needs regarding specific employees or groups or equipment.

• Lead deviation investigations using root cause analysis tools; Author and execute change control and corrective / preventative actions; Authors and/or approves Standard Operating Procedures (SOPs), Batch Production Records (BPRs) and reports.

• Identify and inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results as it relates to GMP compliance; Write and revise SOPs (Standard Operating Procedures), proactively identifying gaps; Identify needed improvements for safety and provide on the floor manufacturing support.

• Other duties as assigned

The Candidate:

• Master's Degree or Ph.D. in technical discipline (e.g., biology, biotechnology, engineering) or related life science field OR Bachelor's Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 3 years’ related experience, OR Associates Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 6 years’ related experience, OR High School Diploma with minimum of 7 years’ related experience.

• Ability to learn and use quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, Chromatography (e.g. Unicorn®), etc; •Proficient in Excel, Word, and other office systems.

• Ability to understand and independently apply CGMPs to everyday work; Intermediate understanding of pharmaceutical laboratory and/or production operations.

• Ability to interpret data and analyze trends to provide insight into potential issues; Ability to lead technical calls and discussions regarding investigations, audits, or other issues.

• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening; Occasional stooping, kneeling, crouching, bending, carrying, grasping; Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• 19 days of PTO + 8 paid holidays

• Employee Stock Purchase Program

• Tuition Reimbursement

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .