Manager, Analytical Development - Madison, United States - Catalent Pharma Solutions

Description

Job Title: Manager, Analytical Development

City: Madison

State : WI

JOB DESCRIPTION :

• Lead a group comprised of people leaders and a range of scientists and support personnel through senior levels. Hire, train, motivate, lead, develop, and evaluate staff (direct reports and others), setting and tracking progress against clear goals and expectations, ensuring constructive feedback, identifying and addressing performance-related concerns and issues promptly and developing knowledge, skills, and abilities towards performance improvement and employee's career development.
• Communicate effectively and provide/support detailed written and verbal instruction; ability to clearly communicate and provide leadership to other groups and clients as necessary.
• Direct experience in method development and experience leading teams engaged in development of a variety of analytical methods and platforms, including several of the following: SDS-PAGE/Agarose Gel analysis, ELISA and Western Blot analysis, various U/HPLC based methods, CE, cIEF, product binding/activity assays, LC-MS, qPCR, and Sanger Sequencing and provide technical and strategic oversight associated with development of robust GMP analytical method platforms, compilation of analytical data, including communicating project status, trend identification, and delivering internal or client presentations.
• Apply technical, functional, business, and/or industry knowledge to design experiments or project scopes; provide scientific, strategic and/or business consultation risk assessments, gap analyses to other teams at the site and executive leadership team and manage multiple functions and/or focuses across sites and disciplines.
• Manage strategic or continuous improvement activities within the lab, across the teams within the department, or across multiple departments within and across sites based upon best industry practices, experimental results, and/or scientific information; and communicate such activities across sites.
• Support proposal review and interact with customers during meetings as a first line in escalations; provide responses to customer's questions. Communicate critical and timely updates to department, site and executive leadership, as required.
• Evaluate existing processes and platforms to identify systems, analytical applications or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Author and review documents including analytical methods, testing, and technical transfer reports.

EDUCATION ANDEXPERIENCE : Requires a Bachelor's degree in Biotechnology and 6 years of experience in the job offered or 6 years of experience in the Related Occupation.

RELATED OCCUPATION:

2 years of experience as a Group Leader or any other job title performing the following job duties:

• Leading the Analytical Development Group;
• Developing robust analytical methods in support of process development and transfer to the quality control group for validation and application to testing the quality of manufactured biological products;
• Collaborating with clients and internal customers to deliver world class analytical methods to support process development and generating robust methods to support Good Manufacturing Practices (GMP) testing of biologics products;
• Developing and training Junior Members of the Team;
• Enhancing value of analytical and protein characterization studies;
• Developing and supporting team, department, and organization training improvements to enhance operational efficiencies;
• Utilizing analytical techniques including HPLC/UPLC, CE and iCE SDS-Page, Western, and Elisa and other biochemical analyses/methods applied to the analysis of biologics and their quality attributes;
• Performing experimental design, statistical analysis, and the interpretation of analytical data; and
• Authoring and reviewing protocols, reports, and procedures for regulatory submission.

4 years of experience as a Scientist or any other job title performing the following job duties:

• Performed recombinant protein purification process steps including buffer preparation, chromatography and filtration;
• Operated, maintained and troubleshot stirred vessel bioreactors, incubators, chromatography columns, and filtration apparatus;
• Developed and optimized analytical methods to characterize proteins and antibodies;
• Reviewed analytical data and reports ensuring accuracy and consistency.

JOB TIME : Full Time

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 ) 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.

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