Sr. Manager Or Associate Director, Manufacturing Downstream

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:

As the Senior Manager or Associate Director of Manufacturing, Downstream you occupy a pivotal role in orchestrating the seamless operation and unwavering compliance of our manufacturing processes. Your leadership spans across strategy, operations, and compliance, setting the course for excellence. With a relentless commitment to upholding cGMP standards, you ensure the consistent delivery of high-quality outputs. Leads and empowers associate-level employees, driving impactful actions across functional areas. Develop and cultivate positive client and internal Avid group (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships.

• Take the helm in devising and executing the strategic vision for downstream manufacturing operations.

• Lead, mentor, and empower a team of skilled professionals, fostering a culture of excellence, innovation, and growth.

• Oversee all aspects of downstream manufacturing operations, meticulously planning and executing production activities.

• Demonstrate proficiency in critical purification operations, including column chromatography, nano-filtration, and tangential flow filtration.

• Uphold the highest standards of cGMP documentation and compliance, ensuring rigorous accuracy and completeness throughout all manufacturing processes.

• Initiate, review, and enhance essential documents such as Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms, and Batch History Records (BHRs).

• Leverage your discerning eye to identify, escalate, and meticulously document deviation reports (IRs/DRs/CAPAs).

• Play a pivotal role in ensuring that all manufacturing operations align seamlessly with internal and external regulatory requirements.

• Collaborate effectively with other departments, harmonizing manufacturing, validation, and maintenance activities.

• Spearhead the introduction of new manufacturing processes and critical equipment, seamlessly integrating them into the production line.

• Your proactive approach enables you to swiftly identify and address complex technical, procedural, and equipment issues that may hinder production and compliance.

• Foster a culture of open communication, not only within your team but also with senior leadership and other departments.

Minimum Qualifications:

• An advanced degree in a relevant field, such as Biology, Biotechnology, or Chemical Engineering.
• A minimum of 10+ years of hands-on cGMP purification experience, showcasing your depth of expertise.
• A minimum of 7+ years of leadership experience, or an equivalent combination of experience, demonstrating your ability to lead, inspire, and guide teams effectively.

Preferred Qualifications:

• Previous experience as a Manager in a CDMO.

• Proven track record of New Product Introductions.

• Extensive experience in leadership development through training and mentoring.

• Excellent time management skills and ability to prioritize workload of self and team.

• This position will be offered as a Senior Manager or Associate Director, based on qualifications of applicant.

We will differentiate between a Senior Manager and an Associate Director based on a candidate's experience and qualifications. Candidates with extensive leadership experience and a proven track record of success in similar roles may be considered for the Associate Director position. Conversely, those with relevant experience who demonstrate strong potential may be considered for the Senior Manager role. The final title and responsibilities will be determined during the hiring process to ensure the best fit for both the candidate and the organization.

Position Type/Expected Hours of Work:

This role is a full-time position operating Monday through Friday. The employee must also, if instructed, be able to work overtime, holidays and/or weekends when needed.

Compensation:

We offer competitive compensation packages for this role, including a base salary, equity grants, 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 $107,000 - $150,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($107,000 - $150,000) plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being.

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 20 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.