POSITION DESCRIPTION
Title: |
R&D Director (CHINA) |
Position Type: |
Full-time |
FLSA Status: |
Exempt |
Job Code: |
|
Department: |
Research and Development |
Effective Date: Location: |
ImmediatelyWuhan, China |
A. POSITION SUMMARY:
PuraCap Pharmaceutical LLC is a fast growing New Jersey private-hold pharmaceutical company, who has operations globally. PuraCap Pharmaceutical LLC develops, manufactures and supplies pharmaceutical products to the healthcare industry in US and worldwide market. PuraCap China subsidiary is a joint venture company of Humanwell Healthcare Group in Wuhan, China. The R&D Director located in Wuhan, China will direct, develop and implement activities focused on the design, development and manufacturing of new products / ANDAs in compliance with FDA and CFDA regulations, as well Company Guidelines. This position will report to the Senior R&D executive in the PuraCap US region.
For more information, please check www.PuraCap.com
B. MAJOR DUTIES/RESPONSIBILITIES:
- Work with cross-functional team members, to lead and manage R&D department in the product development project plans and budgets, key deliverables and timelines to ensure timely completion of projects.
- Oversee R&D day-to-day activities in PuraCap China region; communicate with US R&D department and working very closely with China Manufacturing team to lead the development of Products.
- Encourage creativity in R& D teams to ensure success.
- Maximize product profitability and improve product performance, supporting R&D projects participating in meetings and sharing “best practices.”
- Recruit, select and evaluate staff and develops staff ensuring the correct application of tools and policies on training and development.
- Develop effective relationships with FDA, China FDA and other appropriate Federal agencies.
- Represent and participate in internal and external audits.
- Establishes and maintains operational budgets for R&D team personnel and equipment.
- Actively searches for new technologies and develops innovation roadmap
- Coordinated personnel defining the right allocation of resources.
- Problem Solving: Under limited supervision, make decisions which impact product development activities – launches, applied research projects, R&D strategies.
- Maintain confidential information and intellectual property (IP) includes Product development information. Interpersonal contacts with all departments, including Quality and regulatory personnel.
- Perform other duties as assigned.
- Complies with departmental and company policies.
The above statements are intended to describe the general nature and level of work being performed in this job. They are not intended to be construed as an exhaustive list of all responsibilities and skills required for the person doing this job.
C. ORGANIZATIONAL RELATIONSHIPS:
Reports to: Senior R&D executive in PuraCap US region.
D. MINIMUM/PREFERRED REQUIREMENTS:
Education: |
- Masters Degree in science related field, Pharmaceutical science, Chemical Engineering
- Ph.D. degree preferred
|
Experience: |
- Working experience in a pharmaceutical environment
- Good knowledge of R&D processes and organization in pharmaceutical environment is needed
- Understanding and proved success in new drug development, familiar with QbD and PDR
- Understanding and hands-on experience of Soft Gelatin Capsule is a plus
- Familiar with generic drug development is a plus
- Minimum 5 years in R&D supervisory/ Management roles.
- Strong leadership and communication skill is needed
- Capability in managing people and handling complexity in a multicultural environment is needed
|
Additional Skills/Knowledge: |
- Comply with Company policies, procedures, rules and regulations.
- Ability to comply with Quality Management Systems, applicable laws and regulations
- Ability to apply current FDA and CFDA regulations
- Previous proven success to promote team work among different functions and measuring performance, output and KPIs is preferred
- Bilingual in Chinese and English is a must, a further language is appreciated
- Excellent Computer skills
- Willingness to work flexible hours
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E. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:
- Laboratory and office environment
- Ability to stand/walk on hard surfaces for extended periods of time
PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.
PuraCap offers a generous benefits package and competitive salary commensurate with experience.
TO APPLY:
Email cover letter with resume to: humanresources@puracap.com and in email subject include
“ R&D Director China”