Human Resources (HR) Manager

• Manager, Human Resources
• On-site · Human Resources · Full time
• Milpitas, California, United States

Description

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities.

Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.

CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide.

In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.

We are seeking qualified individuals to join us as Human Resources Manager. Core duties and responsibilities include the following:

Job Duties:

Lead the HR function across Yowei Therapeutics, Yowei Oncology, and shared CSBio teams; manage day-to-day HR operations, priorities, and any HR coordinators or outside HR service providers.

Maintain a regular on-site presence in Milpitas to understand how laboratory, manufacturing, clinical, and pharmacy teams work, build trust with employees, and respond to people issues in real time.

Run full-cycle recruiting for scientific, clinical, pharmacy, quality, laboratory, and operations roles, including workforce planning, job descriptions, sourcing, interview coordination, offers, and background checks.

Protect the companies' stealth status throughout hiring and HR operations by managing confidential postings, candidate NDAs, controlled communications, and need-to-know access to information.

Own onboarding and offboarding, ensuring new hires complete required safety, GMP, data-integrity, and role-specific training before starting regulated work.

Partner with Quality Assurance to maintain training records, curricula vitae, job descriptions, and qualification files that are complete, current, and inspection-ready for FDA, customer, and internal audits.

Track professional licenses, registrations, and certifications for pharmacists, pharmacy technicians, clinical staff, and other credentialed personnel, including renewals and primary-source verification, as the 503A pharmacy model and clinical programs develop.

Administer payroll, benefits, leave, and open enrollment across multiple legal entities in coordination with Finance, brokers, and the payroll provider; ensure accurate employee classification and entity assignment.

Develop and maintain salary ranges, offer guidelines, and job leveling benchmarked to Bay Area life-sciences market data and compliant with California pay-transparency requirements.

Ensure compliance with federal and California employment law, including wage-and-hour, meal and rest breaks, overtime, FMLA/CFRA, ADA, Cal/OSHA, I-9, EEO, and required postings and reporting.

Advise managers on performance management, coaching, corrective action, accommodations, and terminations; conduct fair, timely, and well-documented workplace investigations.

Build and maintain the employee handbook, HR policies, and HR SOPs, keeping them aligned across entities and updated as laws and the business change.

Run the annual performance review and goal-setting cycle and support career development and retention for scientists, technicians, and clinical staff.

Manage HR vendors, including the HRIS, payroll, benefits brokers, background-check providers, recruiting agencies, and employment counsel, and the approved HR budget.

Coordinate employee rewards and recognition, company social events, and quarterly team-building activities.

Track and communicate HR metrics including time-to-fill, offer acceptance, turnover, training compliance, license renewal status, and open investigations.

This is not a desk-only administrative role. The Manager is expected to know the teams, the work, and the regulated environment well enough to give practical guidance on the floor when managers and employees need it.

The Manager must be able to build HR processes from the ground up, train managers, review personnel files and records, and make sound decisions about when an issue can be resolved directly or requires escalation to leadership or counsel.

The role requires balancing hands-on HR operations with planning, policy development, people management, meetings, and cross-functional coordination.

Requirements

• Bachelor's degree in human resources, business administration, organizational psychology, or a related discipline.
• 6+ years of progressive HR experience, with at least 3 years in biotech, pharmaceutical, CDMO, clinical, or another FDA-regulated or GMP environment.
• 2+ years of experience leading an HR function or serving as the senior HR generalist for a company of 50–250 employees.
• Working expertise in California employment law, wage-and-hour compliance, leave administration, and employee relations investigations.
• Hands-on experience with payroll, benefits administration, and HRIS platforms; multi-entity HR experience preferred.
• Strong understanding of GMP training documentation, personnel qualification records, and HR's role in supporting regulatory and customer audits.
• Demonstrated ability to recruit scientific and technical talent, coach managers, set priorities, and handle confidential matters with discretion in a fast-moving, startup-stage environment.
• Strong written and verbal communication and the ability to work effectively across Manufacturing, Quality Assurance, Quality Control, Clinical, Finance, and executive leadership.
• SHRM-CP/SCP or PHR/SPHR certification preferred.