CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

This is employee #1 in Montana, reporting directly to the CEO. The role owns the people‑facing and policy‑facing work streams that are critical for Day‑1 revenue under SB‑535. Engineering, construction and cGMP manufacturing oversight will be handled by a separate Facilities/Manufacturing lead.

Job Duties:

Core Responsibilities (70 % external / 30 % internal)
Patient‑Pipeline Development
- Build and execute the referral network with U.S. oncologists and concierge‑medicine firms
- Own the digital funnel (webinars, targeted advertising, lead‑qualification).
Patient On‑Boarding & Monitoring
- Stand‑up remote‑monitoring tech stack (EHR integrations, wearables, tele‑oncology)
- Chair weekly Multidisciplinary Tumor Board; ensure data flow into Real‑World Evidence (RWE) database for DPHHS
Government & Stakeholder Relations
- Primary liaison to DPHHS, State Legislature health committees, and Governor's Office of Economic Development
- Draft and deliver Annual Safety & Outcomes Report; coordinate facility tours and testimony
Community & Foundation Interface
- Manage CSBio Foundation subsidy programme; identify and onboard 10+ Montana residents in the pilot year
- Lead rural‑access initiatives with local hospitals
Programme Management (Non‑Construction)
- Track timelines for licensure, treatment‑center fit‑outs, and concierge‑care rollouts using Agile/Kanban toolset
- Run cross‑functional war‑room calls (clinical, finance, legal). Escalate risks to executive team
Finance & Incentive Coordination
- Partner with CFO to secure and service the Montana Facility Finance Authority below‑market loan (covenant tracking, community‑impact reporting)
- Prepare grant/credit applications (workforce training, rural‑health funds)
Brand & Reputation Safeguard
- Establish Code‑of‑Conduct for marketing claims; monitor competitors and flag "bad actors" to DPHHS
- Represent CSBio on state Right‑to‑Try working groups to advocate higher compliance standards

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.
Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events

Requirements

10+ yrs in clinical‑operations or patient‑services leadership (oncology, specialty pharmacy, or concierge medicine)
Demonstrated success in government affairs or public‑health policy—ideally at the state level
Proven track record hitting patient‑acquisition or revenue targets in a regulated setting
PMP or equivalent programme‑management certification preferred
Comfort with financial modeling & loan‑covenant reporting
Superb public‑speaking and stakeholder‑management skills
Thorough understanding of problem-solving, safety and quality improvement tools and techniques
Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

Benefits

Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
401k 10% 1:1 match
Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
Disability insurance 50% standard employer paid
Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
PTO policy. 10 days PTO
Cell phone reimbursement
Employee rewards and recognition program
Company organized social events
Quarterly sponsored team building activities

CSBio jobs

Director, Patient Operations and Government Affairs