Biologicals Product Development Specialist

Vor 6 Tagen

Mannheim, Baden-Württemberg, Deutschland Knoell Vollzeit

About Knoell

Knoell is a leading global service provider in the field of regulatory registration, clinical development, and product development support for clients in the animal health industry.

Our team of scientific and regulatory experts, combined with our extensive network of partners, ensures that all regulatory requirements are met from the project outset to support our clients' global business.

Our company values are centered around teamwork, mutual support, and a strong international cooperation, which enables us to deliver high-quality services to our clients.

Our Strength

We pride ourselves on being where it matters - thinking globally and acting locally.

Role Description

The successful candidate will provide strategic regulatory and technical support to the development and registration of veterinary biologicals.

Your Key Responsibilities

  • Provide regulatory advice, technical guidance, and product development strategy in relation to new and existing biological products.
  • Review and critique client documentation intended for regulatory submissions to ensure that relevant regulatory/technical requirements are met.
  • Apply technical, scientific, and regulatory knowledge to provide clients with scientifically justifiable, regulatory compliant solutions.
  • Prepare high-quality scientific dossiers and documents for regulatory submission.
  • Lead regulatory agency negotiations prior to and during regulatory procedures to obtain new and maintain existing licenses.
  • Participate in multi-disciplinary product development teams and provide expert regulatory knowledge.
  • Develop and maintain an in-depth knowledge of relevant regulatory legislation and guidelines.
  • Establish and maintain effective working relationships with clients to ensure a clear understanding of timelines and scope of work.
  • Manage timely delivery of agreed deliverables on client and internal projects.
  • Actively contribute to internal activities and processes that benefit the team.
  • Represent the company in generating new business leads and proactively pursue potential business opportunities.

Key Requirements

  • Strong technical expertise in all aspects relevant to biological product development (vaccines and/or biotherapeutics) including manufacturing and quality aspects.
  • A working knowledge of the EU Veterinary Medicines regulatory framework, European Pharmacopoeia, and relevant guidelines.

Your Profile

  • Proficient in written and spoken English.
  • BSc in a relevant scientific or veterinary discipline; a higher degree is preferred.
  • Ideal candidate has a minimum of three years in biological product development gained in the animal health space or related sector. Appropriate research experience will also be considered.
  • The successful candidate must demonstrate aptitude to develop and grow with the business; must be an empathetic team player; professional and enjoy working flexibly within a highly motivated team.

  • Biologist (m/f/d) - Biological Safety Specialist

    Vor 6 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **Join Our Team at GULP – Experts United****About the Role**We are seeking a highly skilled Biological Safety Specialist to join our dynamic team at GULP – Experts United.**Key Responsibilities**Conduct independent risk assessments (AR) in accordance with the German Ordinance on Biological Substances (BioStoffV) in collaboration with specialist...

  • Biologist (m/f/d) - Biological Safety Specialist

    Vor 7 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **Join Our Team at GULP – Experts United****About the Role**We are seeking a highly skilled Biological Safety Specialist to join our dynamic team at GULP – Experts United.**Key Responsibilities**Conduct independent risk assessments (AR) in accordance with the German Ordinance on Biological Substances (BioStoffV) in collaboration with specialist...

  • Biologist (m/f/d) - Biological Safety Specialist

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **Join Our Team at GULP – Experts United****About the Job**We are seeking a highly skilled Biological Safety Specialist to join our dynamic team at GULP – Experts United. As a key member of our team, you will play a crucial role in further developing cutting-edge technologies and optimizing processes in our innovative automation solutions for...

  • Biologist (m/f/d) - Biological Safety Specialist

    vor 2 Wochen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **Join Our Team at GULP – Experts United****About the Job**We are seeking a highly skilled Biological Safety Specialist to join our dynamic team at GULP – Experts United. As a key member of our team, you will play a crucial role in further developing cutting-edge technologies and optimizing processes in our innovative automation solutions for...

  • Entry-Level Product Development Specialist

    vor 4 Wochen

    Mannheim, Baden-Württemberg, Deutschland PXG Pharma GmbH Vollzeit

    Entry-Level Product Development Specialist (m/f/d) Join a leading healthcare organization dedicated to delivering essential medicines and health products across Europe. At PXG Pharma GmbH, we pride ourselves on our commitment to quality and innovation in the pharmaceutical sector. As a prominent player in the market, we are looking for a motivated...

  • Product Development Manager

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland PXG Pharma GmbH Vollzeit

    About PXG Pharma GmbHPXG Pharma GmbH is a leading healthcare business based in Germany, offering a wide range of high-performance food supplements, medical devices, cosmetics, medicines, and personal care products. We are active in 17 countries and provide over 400 products across various premium brands.Your RoleWe are seeking a Junior Product Manager to...

  • Product Development Manager

    Vor 6 Tagen

    Mannheim, Baden-Württemberg, Deutschland PXG Pharma GmbH Vollzeit

    About PXG Pharma GmbHPXG Pharma GmbH is a leading healthcare business based in Germany, offering a wide range of high-performance food supplements, medical devices, cosmetics, medicines, and personal care products. We are active in 17 countries and provide over 400 products across various premium brands.Your RoleWe are seeking a Junior Product Manager to...

  • Product Development Manager

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland PXG Pharma GmbH Vollzeit

    About PXG Pharma GmbHPXG Pharma GmbH is a leading healthcare business based in Germany, offering a wide range of high-performance food supplements, medical devices, cosmetics, medicines, and personal care products. We are active in 17 countries and provide over 400 products across various premium brands.Your RoleWe are seeking a Junior Product Manager to...

  • Product Development Manager

    vor 2 Wochen

    Mannheim, Baden-Württemberg, Deutschland PXG Pharma GmbH Vollzeit

    About PXG Pharma GmbHPXG Pharma GmbH is a leading healthcare business based in Germany, offering a wide range of high-performance food supplements, medical devices, cosmetics, medicines, and personal care products. We are active in 17 countries and provide over 400 products across various premium brands.Your RoleWe are seeking a Junior Product Manager to...

  • Hardware Development Specialist

    Vor 2 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **About GULP – experts united**We are a leading provider of innovative solutions in the service industry, and we are currently seeking a highly skilled Hardware Development Specialist to join our team.**Your Role**As a Hardware Development Specialist, you will play a key role in supporting the product development process from concept to launch. Your...

  • Hardware Development Specialist

    Vor 2 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **About GULP – experts united**We are a leading provider of innovative solutions in the service industry, and we are currently seeking a highly skilled Hardware Development Specialist to join our team.**Your Role**As a Hardware Development Specialist, you will play a key role in supporting the product development process from concept to launch. Your...

  • Hardware Development Specialist

    Vor 7 Tagen

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **About GULP – experts united**We are a leading provider of innovative solutions in the service industry, and we are currently seeking a highly skilled Hardware Development Specialist to join our team.**Your Role**As a Hardware Development Specialist, you will play a crucial part in our product development process, working closely with our team to design,...

  • Hardware Development Specialist

    vor 1 Woche

    Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    **About GULP – experts united**We are a leading provider of innovative solutions in the service industry, and we are currently seeking a highly skilled Hardware Development Specialist to join our team.**Your Role**As a Hardware Development Specialist, you will play a key role in supporting the product development process from concept to launch. Your...

  • Product Development Engineer

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland 潍柴雷沃智慧农业科技股份有限公司 Vollzeit

    About the RoleWe are seeking a highly skilled Product Development Engineer to join our team at Weichai Lovol's engineering center in Mannheim. As a key member of our team, you will be responsible for designing and developing innovative products that meet the needs of our customers.Key ResponsibilitiesDesign and develop new products and product...

  • Product Development Engineer

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland 潍柴雷沃智慧农业科技股份有限公司 Vollzeit

    About the RoleWe are seeking a highly skilled Product Development Engineer to join our team at Weichai Lovol's engineering center in Mannheim. As a key member of our team, you will be responsible for designing and developing innovative products that meet the needs of our customers.Key ResponsibilitiesDesign and develop new products and product...

  • Product Development Engineer

    Vor 7 Tagen

    Mannheim, Baden-Württemberg, Deutschland Westinghouse Electric Company LLC. Vollzeit

    **About Westinghouse Electric Company LLC.**We are a leading provider of clean energy solutions, and we're seeking a talented Product Development Engineer to join our team.**Key Responsibilities:**Develop innovative concepts for the repair of nuclear power plant main componentsSupport the development, testing, and qualification of equipment/products with our...

  • Product Development Engineer

    Vor 6 Tagen

    Mannheim, Baden-Württemberg, Deutschland Westinghouse Electric Company LLC. Vollzeit

    **About Westinghouse Electric Company LLC.**We are a leading provider of clean energy solutions, and we're seeking a talented Product Development Engineer to join our team.**Key Responsibilities:**Develop innovative concepts for the repair of nuclear power plant main componentsSupport the development, testing, and qualification of equipment/products with our...

  • Material Declaration Product Safety Specialist

    Vor 5 Tagen

    Mannheim, Baden-Württemberg, Deutschland Roche Vollzeit

    About the RoleWe are seeking a highly skilled Product Safety Specialist to join our team at Roche. As a Product Safety Specialist, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key ResponsibilitiesData management and master data maintenance in SAP EH&S(M) and, in future, S/4HANA and chemical law...

  • Material Declaration Product Safety Specialist

    Vor 7 Tagen

    Mannheim, Baden-Württemberg, Deutschland Roche Vollzeit

    About the RoleWe are seeking a highly skilled Product Safety Specialist to join our team at Roche. As a Product Safety Specialist, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key ResponsibilitiesData management and master data maintenance in SAP EH&S(M) and, in future, S/4HANA and chemical law...

  • Product Development Engineer

    Vor 2 Tagen

    Mannheim, Baden-Württemberg, Deutschland Westinghouse Electric Company LLC. Vollzeit

    **About Westinghouse Electric Company LLC.**We are a leading provider of clean energy solutions, and we're seeking a talented Product Development Engineer to join our team.**Key Responsibilities:**Develop innovative concepts for repairing nuclear power plant main componentsSupport the development, testing, and qualification of equipment and products with our...