(Archived) Product Development Manager, CMC - Portland ME, Overland Park, KS or Remote

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Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Product Development Manager, CMC, is responsible for ensuring timely development of products that meet the standards of relevant regulatory authorities to support animal drug applications for a broad range of dosage types.

The Product Development Manager, CMC will be the CMC technical lead for all CMC aspects and/or lead one or more global development projects in research and development through all stages required to obtain regulatory approval for sale in global markets. This position requires management of outside resources, leadership of project teams as well as being the technical lead in the multidisciplinary project team.

The Product Development Manager, CMC works closely with the internal-partners in various functions as well as external and contract manufacturers and labs to ensure the products meet the expectations of multiple regulatory authorities as well as the company's Product Development goals and standards. He/she partners with technical experts in Pharmaceutical Development, Regulatory, Quality and Manufacturing, to review and create technical documents that when submitted to the relevant Health Authorities, will result in a comprehensible review.

The Product Development Manager, will provide technical expertise and leadership in the field of pharmaceutical product development, technical transfer, scale up and validation.

The Product Development Manager, CMC will be a member of the Product Development team and report to the Head Global CMC.

Main Responsibilities

• Ensure timely development of products that meet the standards of relevant regulatory authorities as well as cGXP and Dechra quality standards to support animal drug applications for broad range of dosage types.
• Is overall responsible for all drug substance and drug product activities from preclinical development through clinical supplies for registrations studies and commercial launch.
• Applies understanding of regulations to develop CMC information necessary to support each stage of new product development.
• Proactively considers and directs next steps in CMC development in order to meet project timelines and to ensure CMC requirements do not become rate limiting to the next stage of development and/or registration goal.

As a CMC Lead:

• Provide technical leadership and oversight of formulation development, analytical method development, manufacturing and packaging process development, manufacturing and packaging of pilot, engineering, registration and process validation batches and (VICH) stability studies of product development projects. Activities can be performed either at an internal pharmaceutical development laboratory and manufacturing site or at a contract manufacturing organization.
• Keep abreast of advances and technologies in the field and applies these technologies to support the development project.
• Collaborate with Procurement, DPM and/or DPM to provide COGs estimates
• Responsible for creation, oversight and execution of the CMC project plan. Ensure CMC project deliverables meet the program needs, timelines and cost constraints and are aligned to the overall regulatory and development strategy.
• Communicate CMC resource requirements for product development within project teams so that scope, timeline and budgets can be assembled accordingly.
• Keep stakeholders and project lead informed of progress, issues, risk, key decisions and spend
• Leverage technical expertise and consider the evolving regulatory landscape to navigate the development process.
• Assess the viability of the proposed manufacturing processes and analytical technology identifying shortfalls and/or problem areas. Defines mitigation and/or contingency plans, executing scenario planning and risk assessments.
• Authors and/or provides critical review of technical protocols, product development reports, batch records and CMC sections for regulatory filling. Including preparing and/or critical review of responses to deficiencies and CLOQs.
• Work closely with efficacy and safety technical leads as well as Marketing and the project lead to agree on correct dose/formulation strength/size and number of dosage units (if applicable) ensuring optimal dosing
• Provide test article of the required quality standards for clinical studies
• Establish and maintain necessary collaborations with external partners, such as API suppliers, manufacturers, IP license holders, patent advisors and scientific experts in the field.
• Provide technical support to DPM and Technical Services during product handover and launch.

As a Project Lead:

• Accountable for the overall planning, reporting, and execution of the project, engaging and working closely with the project team to provide clear direction.
• Lead the project team to successful registration and launch of the product. Consistently achieve project goals with the project team
• Ensure coordination and alignment of CMC activities with the other project work streams (clinical, safety, efficacy, labelling) and functional groups.
• Energize, inspire and lead team members to maximize the potential of both of the group and of the individuals within, understanding individual 's need and providing specific and differentiated support to ensure best outcome for the project and the team.
• Ensure the project team executes and completes the project and that the project is delivered within the approved budget, schedule and scope.
• Take decisions, consult with key stakeholders and escalate issues that cannot be resolved in the team.
• Prepare, design and implement the research and development plan, including tasks, status reports, timing and cost of project activities.
• Responsible for regular updates to the Senior Executive Team on timelines, costs and risks of the project, working closely with Project Management.
• Interaction with Regulatory Agencies (e.g. FDA, EMA), working closely with Regulatory Affairs.

Key Performance Indicators

• Delivering pharmaceutical development activities as per agreed project timelines. Assumes responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
• Projects are executed in compliance with Regulatory and Compliance (GMP and EH&S) requirements
• Processes and compliance including; risk management, corporate governance, financial rigor, quality processes, business planning, site strategy.

Skills

• Strong communicator, ability to communicate effectively both verbally and in written formats
• Strong team building and interpersonal skills, ability to work in a matrix environment
• Able to bring a creative approach to resolve issues
• Excellent problem solving and decision making
• Self-motivated, driven and resourceful
• Highly organized and detail oriented
• Results focused. Committed to ensuring projects are completed correctly and on time. Setting priorities and planning
• Ability to effectively multi-task and work under pressure with multiple competing priorities
• Versatility and flexibility and a willingness to work with constantly changing priorities with passion and enthusiasm

• Working knowledge of pharmaceutical products including tablets, capsules, parenterals or semisolids
• Understanding of method validation, stability testing, process validation, quality assurance
• Strong organizational and problem solving experience.
• In depth knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations
• Demonstrated technical leadership experience
• Strong verbal and written communication in English