Posted to MedZilla on 6/26/2019

Takeda Pharmaceuticals

US-MA, Sr. Analytical Development Specialist SR0035600-MZ


Primary Duties:

  • As a member of Analytical Development Method Development team, he/she will work on method development, qualification and characterization of drug substance, drug product and reference standards for biological programs.
  • Responsibilities include designing experiments per ICH guidelines, flawless execution of experimental studies, documenting results accurately in the laboratory notebooks, writing and reviewing technical reports, generating test methods to support high throughput and QC testing groups, participate in analytical, process development and QC meetings and discussions, etc.
  • Provide quality and regulatory support as needed and actively participate project teams.
  • Applies technical knowledge under minimal supervision to independently execute method development and assay remediation activities.

Key Skills, Abilities, and Competencies:

  • Strong analytical and problem solving skills are required.
  • In-depth knowledge of HPLC, UPLC is required.
  • Peptide map and LC/MS are useful; as is experience with glycan mapping methodologies.
  • Experience with alternative methods: iCE, CE-SDS (LabChip or conventional), SoloVPE, and enzyme activity measurements, including both theory and practice are also desirable.
  • Ability to work successfully in both a team/matrix environment as well as independently.
  • Ability to work in a fast pace environment, manage priorities, and flexible to work on multiple projects.
  • Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential.
  • Excellent written and verbal communication skills are essential.

Complexity and Problem Solving:

  • Complex problem solving skills
  • Understanding of ICH, USP and GMP guidelines
  • Flexible to work on multiple projects

Internal and External Contacts:

  • Internal and external departments
  • CROs and CMOs

Other Job Requirements:

  • Available to participate in early or late meetings/teleconferences
  • Familiarity in Microsoft Office (word, excel, and powerpoint) and JMP

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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