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Company

Original Job Post

Catalent Pharma Solutions · 4 days ago

Principal - Process Development, Drug Substance Lifecycle

Madison, WI

Full-time

Onsite

Senior Level

8+ years exp

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Responsibilities

Work cross-functionally with various departments to ensure the success of a molecule’s lifecycle.

Author and review process characterization protocols and reports.

Own the process knowledge of biologic products throughout development and validation lifecycles.

Prepare and review content for client meetings, focusing on data analysis and adherence to timelines.

Provide technical leadership on strategic initiatives, including tech transfers and process validation.

Drive lifecycle improvements and support deviations and CAPAs.

Train, coach, and mentor others on molecule lifecycle and business challenges.

Assure compliance with company directives and support business strategies for molecule lifecycle.

Review client statements of work and advise on appropriate scope.

Lead or support continuous improvement initiatives and perform other responsibilities as required.

Qualification

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Biopharmaceutical process developmentManufacturing experienceDrug substance lifecycle managementBiologics process developmentCGMP manufacturingReport skillsDocumentation skillsStatistical techniquesRisk mitigationPersonnel managementOrganizational group managementMatrix influenceStatistical software proficiencyMicrosoft Office proficiencyChromatography experienceFiltration experienceBiological manufacturingValidation conceptsGMP environmentQuality risk managementHazard AnalysisFMEAData analysisProject managementTechnical conceptsData interpretationProcess improvementsRegulatory guidance interpretationExceptional attention to detail interpersonal skills

Required

Ph.D. in STEM, or related field with at least 8 years of biopharmaceutical process development or manufacturing experience

MS in STEM, or related field with at least 12 years of biopharmaceutical process development or manufacturing experience

B.S/B.A. in STEM, or related field with at least 15 years of biopharmaceutical process development or manufacturing experience

Demonstrated excellence in prior roles can be a substitute for the minimum years of experience

Knowledge of the principles of drug substance lifecycle management, particularly with respect to biologics process development and manufacturing is required

Successful experience interacting and liaising with internal and external clients, customers, and / or suppliers is required

Experience working on late phase, process characterization, process performance qualification and commercial programs is required

Knowledge and experience working in biologics process development and supporting cGMP manufacturing is required

Exceptional attention to detail and accuracy

Experience in report and documentation skills

Knowledge of statistical techniques for data analysis and reporting

Skilled at risk mitigation for function

Direct personnel and / or organizational group management experience (matrix influence and management), including mentoring and training staff members cross-functionally

Experience with statistical software (MiniTab, JMP, SAS, Tableau, Spotfire) and Microsoft Office, especially Excel and Word. Ability to learn and use software packages (e.g., TrackWise®, ComplianceWire®, Unicorn®)

Lab and/or process scale chromatography and filtration (viral, chromatography, tangential flow) experience

Strong technical knowledge and/or hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment

Capable of rapid learning of unfamiliar principles or techniques with minimum training

Ability to plan, schedule, and carry out work for successful project completion, while integrating timelines and meeting milestones

Understanding and application of quality risk management and associated tools (Hazard Analysis, FMEA, etc.)

Strong interpersonal and presentation skills to discuss technical concepts internally and with clients

Demonstrated ability to understand and relay/incorporate expertise given from technical staff outside their area of expertise to their program

Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions

Ability to troubleshoot and collaborate on complex problems to identity solutions

Ability to provide ideas, introduce new technology, and drive process improvements

Ability to compose letters, outlines, memoranda, and basic reports and/or to orally communicate technical information

Ability to make presentations, inside and/or outside the organization; comfortable speaking before groups

Provide reliable and defendable interpretations of regulatory guidance for the customer and proven capability to defend said positions to regulatory agencies

Preferred

Experience in product / process CMC life cycle management including pre-approval, launch and post-approval stages

Company

Catalent Pharma Solutions

Catalent Inc.

Founded in 2007

Somerset, New Jersey, USA

10,001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent Pharma Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (31)

2022 (66)

2021 (72)

2020 (59)