Industrial Development Technical Lead

Biomune Company

United States, Kansas, Lenexa

8906 Rosehill Rd (Show on map)

Nov 06, 2024

Industrial Development Technical Lead

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

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Location: Lenexa, KS

Job Summary and Purpose:

Responsible for overseeing process development, technical transfer, and process validation of new products and post-Market Approval changes of Ceva products manufactured at pharmaceutical Contract Manufacturing Organizations (CMO) in North America.

Responsibilities and Key Duties:

Manage the product/manufacturing process knowledge transfer between Ceva I&D (Innovation and Development) teams and the CMO and/or the transfer of process and technology between CMOs.
Design/implement/review the technical summaries for transfer, engineering, registration and validation batch documentation and planning with Ceva I&D and the CMO
Manage industrialization meetings with Regulatory, Quality, External Manufacturing and other colleagues to keep updated and aligned on major milestones/timelines for US products.
Apply Quality by Design (QbD) tools for process development along with risk assessment and/or failure mode and effect analysis (FMEA) on manufacturing processes
Provide support when needed for the design, installation, start-up, validation and operation of capital investments dedicated to Ceva products
Perform on-site and paper evaluations (gap analysis) of potential CMOs during the site selection process of new products by reviewing with the selection team the technical capabilities, capacity, facility and operational metrics, safety, quality, regulatory history and other elements key to finding the right partner
Review the CMC section documents related to the manufacturing process prior to regulatory submission
Coordinate and review with the Regulatory and Quality all post-Market Approval activities for approved drugs as well as any other products in the portfolio (e.g. supplements and treats)
Ensure the design and construction of processing equipment/suites dedicated to Ceva products meet the process needs and are executed according to cGMP and are completed within the scope, schedule, cost and quality requirements
Oversee and spend time "on the floor" during engineering, registration and validation activities to ensure proper execution and secure a full understanding of all elements of the process
Review statistical tools, data and methods to understand process variability and capability to drive improvements
Provide input for investigations, commitments, and change controls assuring changes provide robust manufacturing process - ensures changes are value added
Work in conjunction with the Global Industrial Development group to review, write and standardize process and procedures for industrial development across all sites within the Ceva global network

Core Competencies:

* Shape solutions out of complexity

* Client focus

* Collaborate with empathy

* Engage and develop

* Drive ambition and accountability

* Influence others

Technical / Functional Competencies:

1. Cross-functional team leadership

2. Pharmaceutical development knowledge (CMC)

3. Communication Skills - Written and Verbal

4. Analytical skills

5. Professional Judgment and Decision Making

6. Manufacturing technologies knowledge for pharmaceuticals

7. Excel and Statistical software for analyzing data

8. MS Project or other tools to manage complex projects

9. Visio or other software for documenting and analyzing process flows

Qualifications:

Education -

Bachelor's degree is required.

Work Experience -

5+ years of process, production and/or product development experience in the pharmaceutical or applicable manufacturing environment is required.

Other (consider certifications, specialized knowledge and/or training, etc.) -

- Knowledge of cGMP and FDA guidelines and how to apply them effectively is preferred.

- Project management experience is preferred.

- Knowledge of pharmaceutical or equivalent manufacturing.

- Knowledge of QbD tools

- Excellent computer skills.

- Able to manage priorities and projects prioritizing effectively.

- Must communicate clearly and be able to work in a matrix organization.

Physical Requirements:

* Essential Physical Job Tasks: Operation safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking.

Working Conditions:

* Must wear safety glasses, or specified eye protection, in all designated areas

* Must follow any applicable plant safety requirements

* Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration and requirements at manufacturing facilities

Travel Required:

30-40% (Varies based on current project load and product development stages).

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

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