The Company is now seeking to fill a number of highly senior executives to join their team, including a manufacturing/ production Manager.
Generic Specialty Pharma (GSP) is an Irish incorporated generic pharmaceutical company. We are part of the Alter Pharma group, a Belgian group of pharmaceutical companies with focus on the development and manufacturing of pharmaceutical products. We use 3rd Party manufacturers all over the world, all holding valid EU GMP and/or FDA approval. We license out our products to clients all over the world. The team behind Generic Specialty Pharma has significant experience within the European generic industry and today these people are focused on bringing this know-how to Ireland. As Generic Specialty Pharma is a young company, our structure and rapid growth offers special challenges to all our employees.
We intend to add value for our partners all over the world by developing a range of carefully selected products, which are difficult to develop or to manufacture. We are dedicated and committed to cover niche, geographical specific and immature market segments having special focus on the development of well-established molecules.
We are striving for incremental innovation by providing new galenic forms and product strengths with the ultimate aim to increase the quality of life of patients.
We aim to establish a global network of committed licensee’s and distributors to promote and sell our products. To maximize the commercial potential of each product while supporting and engaging with our clients to make a difference.
We will cultivate and grow our competent staff base and continuously search for high value partnerships in developers and manufacturers to achieve our goals.
R&D Production Team Leader
Product Development (R&D)
Nicolaj Donskov Nielsen
R&D Production team
ROLE & RESPONSIBILITIES
- Develop the R&D Production Team and company principles and process related to R&D Production activities (process optimization, registration batch production, validation batch production, post-launch scale-up projects and tech transfer projects to new CMO’s) together with R&D project responsible, Supply team, Regulatory team and QA team.
- Participate in setting out the short- and long term strategy for the R&D department with Head of Department
- Develop principles for tech transfer contracts
- Contribute to the choice of CMO’s, negotiate terms and tech transfer contracts, as well as manage the partners during the R&D Production phase.
- Manage resources and project teams for R&D Production activities.
- Overall responsible for project progress-, budget- and timeline reporting
- Act as R&D Production Specialist for part of the ongoing projects
- To build and evaluate strategies for process, communication and information flow between stakeholders during the R&D Production phase
- To highlight process- and resource bottlenecks, suggest and participate in organizing solutions to improve department workflow
- To report project progress, -budget and timelines and ensure the quality of reporting
- To draft job descriptions for new R&D Production staff, screen candidates, participate in selecting new team members for employment and set team goals
- To allocate projects to the R&D Production staff and manage resources of ongoing projects
- To ensure that the project teams meets the timelines, minimize delays and ensure data quality in company overview files and archives
- To set out the team framework and supervise team in the planning and negotiation of Project budgets and assessment of appropriate project scope
- Act as R&D Production Specialist for part of the ongoing projects.
- Minimum Qualification: MSc or higher in a life science discipline; Course in Project Management andteam leadership is appreciated; Extensive experience with EU and US R&DProduction is desired.
- Minimum Experience: 10 years of experience in a pharmaceutical industry, specifically hands-onexperience with pharmaceutical manufacturing and tech transfers.
- Languages: Good English skills is a must (written and oral)
- A strategic mindset and a leading character with a positive spirit and strong communication- and motivation skills. Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment.
- Ability to manage internal and external project teams in person and remotely.
- Ability to understand different working styles and support team members in achieving department goals
- Proven track record in project management or equivalent with knowledge of project management techniques and tools. Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.