Sr Scientist II

A global leader in the manufacture of cGMP-produced, high purity, injectable grade excipients and bioprocessing solutions. The majority of leading biopharma firms trust us to supply them with critical formulation components for their commercial manufacturing needs

"PERMANENT ROLE" "EXCELLENT TEAM"

KEY SKILLS:

API

HPLC

ICP-MS

EMPOWER

ANALAYTICAL METHOD DEVELOPMENT

ANALAYTICAL METHOD VALIDATION

QC

JOB SUMMARY

Individual will independently design, develop and validate analytical methods while acting as analytical lead for multiple projects. Provide analytical support for research, development, and manufacturing activities. Additionally, this position will support other activities associated with laboratory operation and will review data for compliance, review policy and procedure documents as necessary to meet cGMP regulations and applicable guidelines. Perform training of other scientists on complex and/or specialized analytical techniques. Act as a resource for instrument troubleshooting and guidance to other scientists. Must be able to work in a complex, fast paced environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Conducts daily activities in accordance with the Company Cardinal Rules
• Develop and validation of analytical methods in compliance with ICH guidelines for novel API and excipient products under the guidance of analytical project leader.
• Develop and execution of study plans to assess feasibility of client provided method including development and execution of method validation and implementation.
• Act as project analytical lead. Perform oversight of all methods related to a project, coordination of implementation of methods, support for implementation of IP/PBR/specifications and communications with project management.
• Provide project support through testing requests, compilation and assessment of data, feedback on analysis approach and reporting of findings to supervisor and / or project lead including issues/abnormal observations while striving to adhere to assigned due dates.
• Perform review of existing validations against current standards, generation of gap assessment report and remediation plan to close validation gaps.
• Perform technical and compliance review of complex analytical tests while ensuring scientific integrity.
• Execution of testing protocols without deviation.
• Willingness to work on Safebridge Category I-III compounds.
• Perform training of other scientists on complex and/or specialized analytical techniques.
• Requires full understanding of multiple instruments/methodologies including functionality and the ability to troubleshoot issues.
• Authoring of templated technical documents.
• Maintain analytical equipment (periodic calibration and maintenance) in accordance with PI policies and procedures.
• Maintain files as directed.
• Perform data entry into spreadsheets and proprietary computer systems.
• Operate following company policies and procedures to meet cGMP regulations and ICH guidelines.
• Maintain documentation in an accurate, clear and concise manner in accordance to company policies and procedures.
• Maintain a clean, safe and orderly workplace, following all applicable EHS policies and procedures.

QUALIFICATIONS

• BS or MS degree in chemistry or biology or related field
• 4+ years of experience in a GMP analytical laboratory. Method development and validation experience is preferred.
• Accurate documentation and observation skills
• Strong analytical laboratory skills including all relevant pharmaceutical QC techniques
• Ability to exercise independent intellectual judgment based on their specialized skills in the field of science
• Technical project leadership abilities, including good written and verbal communication skills
• Able to train others
• Working knowledge of the cGMP regulations
• Working knowledge of safe handling practices of dangerous chemicals
• Computer skills (spreadsheet, database and word processing window based programs)
• Hands-on experience with the operation and maintenance of analytical instrumentation preferred. (HPLC and/or GC with Empower, ICP-MS, HPLC-MS, GS-MS)
• Experience with carbohydrate, amino acids, lipids and/or small molecule APIs is desirable

Physical Requirements

• Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant
• Must be able to sit and/or stand for extended periods
• Ability to work effectively under pressure to meet deadlines
• Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
• Must be able to lift 25 lbs. or occasionally lift up to 35 lbs.
• Ability to wear proper safety equipment when working in the laboratory or plant

***Candidates must be up to date on vaccination/booster/flu shots to be considered for employment. If they are not up to date during the screening process that is okay they will just have to wear a mask for the onsite interview(s).

US Citizens or Green card holders only