Principal Scientist, MSAT Early Phase
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Principal Scientist, Manufacturing Sciences & Technology (MSAT) will act as a subject matter expert and will lead a team of specialists with enhanced technical acumen and process knowledge. This role provides the manufacturing process teams support as a technical resource and develops his/her team to aid with complex tasks and supplement routine operations. The Principal Scientist, MSAT will ensure the robustness of manufacturing processes and equipment by driving continuous improvements and applying best practices across manufacturing operations.
Key Responsibilities:
- Conduct technical review of equipment and processes and make recommendations to improve efficiency and robustness.
- Troubleshoot processes/equipment and perform root cause analysis for failures, out-of-trends, and deviations.
- Lead a team of specialists responsible for supporting manufacturing production including supporting process transfers, troubleshooting process failures, supplementing routine operations, and performing investigations for complex deviations.
- Support process transfer from PD/ to Manufacturing.
- Procure and qualify new process equipment required for GMP operations.
- Identify and reduce areas of risk in existing processes.
- Resolve deviations due to process constraints and/or technical challenges
- Perform root cause analysis for equipment failures, support product quality impact assessments and implement CAPA
- Partner with validation, facilities and engineering, and metrology to schedule critical equipment preventive maintenance and/or qualification activities.
- Analyze staffing required to effectively support manufacturing production and make staffing recommendations based on production requirements.
- Must be able to build a collaborative network and influence without direct authority.
- Participate in proactive team efforts to achieve departmental and company goals.
- Provide leadership to others through example and sharing of knowledge/skills.
- Will need to be a self-starter, strongly motivated and able to work independently without supervision.
- Acquire and maintain a clear understanding of the technologies utilized in upstream and downstream manufacturing operations.
- Execute additional short-term projects and assignments to improve manufacturing systems.
- Perform other duties as assigned.
Minimum Qualifications:
- Bachelor’s degree in life sciences or production management.
- Minimum of 5 years of manufacturing operations, manufacturing planning, materials planning and/or project management experience for a pharmaceutical or biotech manufacturing organization.
- Biologics experience is required.
- Experience working with cGMP and ICH Q7A is required.
- Knowledge and understanding of manufacturing processes, equipment commissioning and validation requirements, and familiarity executing process transfer into a manufacturing setting.
Position Type/Expected Hours of Work:
This role is a full-time onsite position in our Costa Mesa, CA location. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $147,200 to $184,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.