Scientist III in Lawrence, Massachusetts

Scientist III

Rangam is seeking candidates for a Direct Hire role as a Scientist III with our client, one of the world's largest pharmaceutical companies. Seeking candidates in Andover, MA or willing to relocate.

Use Your Power for Purpose

• The qualified candidate will provide support for new and existing analytical method development and validation in a cGMP quality control analytical (QCA) laboratory. Supported activities include initial analytical method development, validations, qualifications and compendial verifications in support of clinical and commercial drug substance production. Analytical method validations for PAT methods within production suites will also be supported.
• A host of analytical techniques will be utilized, spanning a wide range of materials, including small molecules, gases, nucleotides, custom media, resins, polymers, salts, sugars, enzymes and others
• This is a fast-paced group managing activities that are tied directly to the Andover production record.
• This role will also have a direct impact on Network Lab Strategy efforts aimed at harmonizing global analytical method strategy across 40 client's sites.

What You Will Achieve

• Develop and validate analytical test methods, author test method documents, support specification and list of test method development and ensure effective method transfer from the technical support group to the release laboratory by training analysts.
• Draft and execute analytical method validation protocols in support of new material qualification
• Provide technical support for new analytical methods, method troubleshooting, investigations and method improvements
• Collaborate with site functional areas such as Global Procurement, Quality Assurance, Site Technical Services and Manufacturing Operations to support the site plan of record.
• Support sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group.
• Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations aimed at mitigation.
• Maintain all related data and records in compliance with cGMPs and quality procedures
• Write and review various technical documents in support of new material validations/verifications, investigations and technical memos.
• Meet all timelines and deliverables in support of Andover plan of record and instrument qualifications (IQ/OQ/PQ).
• Execute method validations for PAT test methods within manufacturing operations.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with 6+ years of experience; OR a master's degree with at least 4 years of experience.
• Knowledge and practical application of relevant basic spectroscopic and chromatographic techniques
• Ability to efficiently manage personal project timelines well is a must
• Working understanding of cGMPs and regulatory guidance
• Experience with GC and HPLC
• Possess strong problem solving skills
• Demonstrated planning and prioritization skills with a focus on team success in meeting defined timelines. A proactive team player.
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)
• Excellent oral and written communication skills

Bonus Points If You Have (Preferred Requirements)

• Experience with Raman spectroscopy preferred
• Experience in method troubleshooting and laboratory investigations preferred
• Working understanding of IMEx principles preferred
• Knowledge of Empower Software.

PHYSICAL/MENTAL REQUIREMENTS

• Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NA

Work Location Assignment:
On Premise

The annual base salary for this position ranges from $82,700.00 to $. In addition, this position is eligible for participation in client's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives…