Associate Lead I - Biomanufacturing, Compliance, Tech Writer

Company: Disability Solutions
Location: Madison
Posted on: November 20, 2024

Job Description:

**Position offering $2,000 net sign on bonus**Position SummaryAssociate Lead I - Biomanufacturing, Technical WritingCatalent 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. --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. The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements.The Associate Lead I - Biomanufacturing, Technical Writing under minimal supervision, authors and revises deviation records, preventative actions, and other related cGMP documents in a timely manner.--Position is 1st shift M-F 8AM-5PM and is 100% on site at Madison, WI facility.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.The Role:--- -- --Becomes familiar with upstream, downstream, materials management, production facility, systems, and technologies to facilitate the accurate completion of responsibilities.--- -- --Tracks/monitors and provides timely, accurate information regarding status of open investigations.--- -- --Engages in initiatives to improve process compliance culture, including on-going cGMP understanding and application.----- -- --Actively engages in Inspection Readiness activities and teams.--- -- --Provides guidance to write and revise SOPs (Standard Operating Procedures) when gaps are identified.----- -- --Assists in supporting internal and client audits as needed; Participate in team meetings.--- -- --Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company's policies and practices.--- -- --Other duties as assigned.The Candidate:----- -- --Bachelor's Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field OR Associates Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 1 years' related experience. Will also consider High School Diploma or GED with minimum of 4 years' related experience.--- -- --Ability to gain a basic understanding of pharmaceutical laboratory and/or production operations; Ability to understand and apply CGMPs to everyday work.--- -- --Experience using Excel, Word, and other office systems.--- -- --Aptitude to learn and use quality, operations and/or scientific management software such as TrackWise--, ComplianceWire--, JD Edwards--, Chromatography systems (i.e. Unicorn--), etc.--- -- --Capable of learning unfamiliar principles or techniques with training; Executes procedures with high quality; Edits Standard Operating Procedures (SOPs) with guidance from supervisor.--- -- --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; detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines; able to cooperate with coworkers within an organized team environment or work alone.--- -- --Safety and Environmental Requirements: 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; Ability to operate within a clean room environment as needed.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----- Tuition Reimbursement----- Wellhub (formerly GymPass) program to promote overall physical wellness--Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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.--personal initiative. dynamic pace. meaningful work.Visit 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 . 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 .

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