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Principal Scientist - Ireland
Want to know company name or location? Company managed [?]
Posted on : 15 May 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Our company is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization.
- The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead-time reduction and efficiency gains to ensure the company’s success in the EMEA Region.
- The incumbent is expected to lead and oversee multiple internal and external sites (CMOs) with focus on building strong compliance posture in routine analytical testing. The individual will interact closely with internal company sites and the CMOs in identifying issues/gaps and implementing solutions, and troubleshooting laboratory test methods and workflows as well as ensuring compliant, robust, and responsive supply.
- The individual will initiate and lead strategic initiatives related to technical strategies, compliance, and/or business improvements.
- The individual will have a deep understanding of the regional regulatory and business environment and the needs related to API and Drug Product development, GMP compliance in commercial manufacturing and data integrity.
- The individual will also be responsible for technical training of staff, as needed, on analytical techniques, problem solving and data integrity.
- In addition, the incumbent will keep up with API and Drug Product regulation changes and facilitating central development group to make adjustment to our company product development strategies.
- A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of cGMP and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize company’s vision.
- Ph.D. degree with 6+ years or BS/MS degree with 12+ years of analytical development experience for API and/or drug product.
- Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents
- Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
- Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
- Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
- Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance and drug product development and registration.
- Have working knowledge of the process by which the products are brought to market.
- Have experience working with CMO’s and CRO’s.
- Have working knowledge of CMC filing requirements.
- Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
- Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
- Self motivated to take ownership and accountability of issues and drive them to completion.
- Ability to speak up and raise issues and help to drive to resolution.
- Ability to quickly adapt to changes and develop appropriate plans for managing risks.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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