Group Manager (Analytical Sciences)

Job Information

Job ID: 81198
Job Title: Group Manager (Analytical Sciences)
Company Name: Way Simmons Partnership
Job Type: Full-time
Division: Chemistry, Manufacturing & Control Department
Location: Hyogo Prefecture
Salary: 10 million yen ~ 17 million yen
Date Refreshed: September 5th, 2008 09:32

General Requirements

Minimum Experience Level: Over 6 years
Minimum English Level: Fluent
Minimum Japanese Level: Native
Minimum Education Level: Bachelor's Degree
Visa Status: Japanese national or permission to work in Japan required

Job Description

Our client, a group of companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life is seeking a Group Manager for their office in Hyogo. The Group Manager will be responsible for developing state of the art analytical methods (e.g., HPLC, GC) and conduct stability studies for new drug products in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.)

・ Method development for new NCEs based on their phys. - chem. properties
・ Maintains and newly establish state of the art technology
・ Supports Pharmaceutical Research developing trial and final formulations
・ Designs and execute ICH and cGMP compliant stability studies applying newly developed analytical methods
・ Determines long-term stability and shelf-life of new drug products
・ Provides guidance to PHR wrt viable formulation approaches
・ Compiles stability reports
・ Summarizes all results and present all relevant data to the international R&D team
・ Communicates and implement all team decisions within the department (matrix management function)
・ Communicates and resolve conflict
・ Plans, prepares and conducts method transfers
・ Trains analytical staff and report results
・ Prepares submission documents for J-NDA and global MAA submissions
・ Interacts with DRA and CMC Experts on content and format of documentation
・ Contributes to establish proactive response strategies
・ Interacts with international regulatory bodies during the development (e.g, pre-NDA meetings, formal and informal discussions, etc.), submission, review and post marketing phase
・ Supports operations in performing quality investigations
・ Trouble shooting and problem solving for commercial products
・ Interacts with partners and customers
・ Coaches staff to acquire skills, help them to solve problems and develop their career plans
・ Provides staff with career development opportunities on-the-job and also off-the-job
・ Leads by example

Required Skills

The successful candidate will have a University degree (Chemistry, Pharmacy, Biology), PhD (Pharmaceutics, Analytical Chemistry), 5 - 10 years of experience in an international pharmaceutical R&D organization, strong analytical background with proven performance record, and a profound knowledge of the development of analytical methods. Native Japanese and fluent English skills are also pre-requisites for this role.

・ University degree in Chemistry, Pharmacy, or Biology (or other life sciences) with a PhD in either scientific discipline (preferably Pharmaceutics or Analytical Chemistry)
・ 5 - 10 years of experience in an international pharmaceutical R&D organization
・ Strong analytical background with proven performance record
・ Experienced leader (direct reports, teams)
・ International work experience (cross-cultural competence)
・ Profound knowledge of the development of analytical methods
・ Relevant GLP, GMP and ICH guidelines
・ Relevant global regulatory guidelines and submission/approval requirements (in particular FDA, EMEA, PMDA)

Company Description

Way Simmons Partnership has offices in Tokyo, Hong Kong and Singapore and provides contingency, advertised and search solutions across the commerce and industry sector. Our recruitment business is categorised as specialist/professional. With many years of experience in search and selection our team of expert recruitment consultants has experience in the following areas:

Executive & Management
Accounting & Finance
Human Resources
Marketing & Sales
Executive Support

We act for Multinational Companies (MNCs), Small to Medium Enterprises (SMEs) and locally grown diversified businesses and employers of choice who understand the value of working in partnership with a totally focused approach to human resource solutions.

All our consultants are able to rapidly understand their clients’ hiring requirements whilst developing a strong relationship of trust with their candidates. Our team prides itself on carrying out their work with the utmost confidentially and integrity and for candidates, there is no charge for the services that we provide.

Way Simmons Partnership is a division of Legal Futures Japan K.K.

Our recruitment business is categorized as specialist/professional and our placements are limited to Japan only. Our service is free of charge. We will apply and follow the laws and principles of all relevant legislation and maintain data privacy at all times. Please refer to www.legalfutures.com to view our Privacy Policy. The person handling personal information is our license holder Matt Anderson who will also handle any complaints.

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