Process improvement manager Jobs in Carlsbad, CA

Description

Key Responsibilities

Lead, mentor, coach, and develop technical staff within and outside the group in all aspects of downstream process development, including protein purification, bioconjugation (antibody-drug conjugates), and new technology implementation.

Design and execute experiments to develop efficient, effective downstream purification processes using multiple chromatography modes, filtration technologies, and ultrafiltration / TFF.

Drive new technology development and implementation to enhance downstream platforms and improve process efficiency.

Author and review technical documents, development reports, SOPs, manufacturing batch records, and CMC sections of regulatory submissions (IND, INDa, BLA).

Transfer downstream processes to manufacturing sites, CMOs, and partner sites, ensuring successful scale-up and implementation.

Represent Downstream Process Development on cross-functional teams and contribute to strategic initiatives.

Produce significant internal / external documents or publications supporting company goals.

Basic Qualifications

BS degree with at least 8 years of industry experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

MS degree with at least 6 years of industry experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

Familiarity with protein conjugation process chemistry and formulation.

Hands-on experience in protein purification, thorough understanding of chromatography, and familiarity with AKTA systems.

Extensive knowledge of impurity removal strategies and product variant control; strong chromatography and / or conjugation experience preferred.

Proven track record in scaling up, transferring, and supporting purification processes from bench to pilot / commercial scale in GMP environments.

Experience with statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts.

At least 3+ years of experience supervising technical staff with strong management and leadership skills.

Excellent organizational skills and ability to manage multiple projects in a fast-paced environment.

Strong communication skills (verbal and written) and ability to build relationships across teams and with external partners.

Preferred Qualifications :

PhD with at least 2 years of experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

The salary range for this position is :

Bay Area : $169,320.00 - $219,120.00.Other US Locations : $153,935.00 - $199,210.00.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans

For additional benefits information, visit :

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.