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Basic Purpose of the Position
To plan, perform, and oversee all activities and personnel of a scientific laboratory, incorporating chemistry, technology, manufacturing knowledge, cGMP knowledge and cost reduction measures.
Accountabilities
1.Manage and support laboratories and production units (internal or external) to achieve key milestones of development process. Daily activities include but not limited to efficiency and productivity
- Independently develops and executes plans to complete assigned project within timeline
- Directs a project team of multiple disciplinary personnel to perform experiments to define process parameters intended for manufacturing and even for commercialization; Must apply organic chemistry, chemical engineering, safety and green chemistry principles to design and execute experiments, optimize reactions, streamline workup procedures, and reduce cycle time
- Defines milestones of a project and operate or coordinate the execution of tasks within defined time frames in order to meet a pre-set project timeline
- Clearly communicates and presents project progress in verbal and in written forms to the various disciplines; Interfaces with functional groups primarily within department and manages project team resources to facilitate project development process
- Writes operating procedures, protocols, batch records, tech packages for scale up, production and transfer if needed
- Identifies and introduces new process technologies, new techniques/equipment and modifies equipment to improve
- Make risk assessments for the laboratory and ensure that the company's Health & Safety policy is adhered to
- Ensure the proper handling, storage and disposal of hazardous materials
- Ensure that any personnel using the laboratory adhere to safety policies and procedures
2.Assist Director in the development and implementation of strategic plans to meet the requirements for deliveries, budget, safety and cGMP compliances, capital projects, FTEs alignment and personnel development
3.Take a leadership role in updating and establishing guidelines, procedures and SOPs to meet current industrial standards
4.Coordinate and address technical and operational challenges related to process development groups
5.Identify improvement opportunity and provide technical and business assessment to senior management
6.Recruit, coach, mentor, train, supervise and develop junior scientific staff and to ensure that entire staff is trained and working in conformance with related requirements, company policies, SOPs and safety regulations
7.Represent the department to companywide initiatives
Required Capabilities (Skills, Experience, Competencies)
1.PhD in organic chemistry and 5+ years pharmaceutical or relevant experience preferably in a scale up environment for the production of intermediates/APIs under cGMP
2.Demonstrated a broad knowledge of organic chemistry, process scale up and manufacturing
3.Outstanding track record in initiation, evaluation and implementation of intermediates/APIs related projects
4.Demonstrated ability to mentor, motivate, organize and lead a multi-disciplinary team
5.Understanding of the fundaments of cGMP and safety regulations and ability to apply the regulations creatively to scale up
6.Must be able to effectively liaise with bench scientists, as well as internal and external customers
7.Excellent project management and presentation skills
8.Excellent time management skills
9.Need to have good analytical and problem solving skills
10.Must be able to make rational decision under pressure
11.Must be able to respond quickly to breakdowns in systems or processes
12.Must pay close attention to details
13.Must maintain a proactive approach to work activities
14.Excellent leadership and managerial skills is a must
15.Fluent English is must
16.Chemical engineering background/experience is a plus but not a must
17.Good German skills is a plus
