All Of Our Groups
Healthcare
Advisor,SmallMoleculeManufacturingProcessQuality
“Advisor, Small Molecule Manufacturing Process Quality at All Of Our Groups. Skills: Small Molecule Manufacturing Process Quality, GMP, Quality Management Systems. creating and maintaining a safe work environment. leading/enabling safety efforts for the Quality team”
What You'll Achieve.
optimize manufacturing processes; increase capacity for clinical trial medicines; reducing costs and environmental impact; support the delivery of the Foundry; build a new organization; develop and implement the necessary systems and business processes required to support GMP operations; build the site culture; support early phase GMP activities
Industry & Context.
Critical thinking and technical problem-solving skills; root cause analysis/troubleshooting skills; Ability to identify and prioritize issues and develop & implement solutions
Travel Percentage: 5% - 15%, May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays
What They're Looking For.
Must Have
BAS degree in Engineering, Science, or related field, minimum of 5 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry, understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems, Qualified applicants must be authorized to work in the United States on a full-time basis
Nice to Have
Experience in API manufacturing of synthetic small molecules and/or high potent antibody drug conjugates (ADC), Experience with applicable equipment cleaning requirements, Relevant industry experience in high paced working environment, Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration, Demonstrated oral and written communication skills, Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills, Flexibility to adjust quickly and effectively to frequent changes and altered priorities, Ability to input and influence decision making for complex technical issues, Ability to establish key relationships and influence peers and business partners, Ability to identify and prioritize issues and develop & implement solutions, High learning agility and ability to deal with ambiguity, uncertainty, Demonstrated attention to detail
What You'll Do.
creating and maintaining a safe work environment
leading/enabling safety efforts for the Quality team
support the execution of the site operational readiness plan
development of early phase quality processes and operational procedures and controls
Ensure compliance with applicable laws
and guidelines to support early phase GMP activities
Review and approve GMP documentation including procedures
Work cross-functionally with the plant teams to develop processes
provide operational support
Assist with inspection readiness activities
Facilitate decision making within the team under tight deadlines
Participate in global communities of practice and committees
establish and maintain a network for benchmarking and share learning
Identify and lead process improvement projects impacting multiple business areas
How You'll Work.
Team & Collaboration
Support cross-functional teams; Foster a collaborative quality culture; promoting teamwork and employee participation in the work group and with cross-functional teams; Work cross-functionally with the plant teams; Facilitate decision making within the team; Effectively communicate with internal and external stakeholders; Participate in global communities of practice and committees; establish and maintain a network for benchmarking and share learning; Ability to establish key relationships and influence peers and business partners
Communication Scope
Demonstrated oral and written communication skills; Effectively communicate with internal and external stakeholders
Process & Methodology
lead process improvement projects
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