Project Manager, cGMP Commercial Readiness
Posted Updated
Description
Serán BioScience provides optimized drug development and manufacturing services from discovery through clinical stages. An expansion is currently underway to provide commercial manufacturing capabilities in 2027. The company uses a science-driven approach, combining predictive design tools, advanced chemistry, analytical capabilities, and enabling delivery technologies with strong quality and regulatory expertise.
The Project Manager, Commercial Readiness serves as the central coordinator for cross-functional readiness activities and is responsible for ensuring organizational preparedness for upcoming commercial manufacturing operations. This role drives accountability, visibility, risk management, and execution of readiness plans across Quality, Manufacturing, Technical Operations, Supply Chain, Validation, Regulatory Affairs, and supporting functions. The position does not directly manage functional resources but is responsible for facilitating alignment and timely completion of readiness deliverables.Viable applicants must have experience supporting a GMP environment
Commercial Readiness Program Leadership
- Develop and maintain integrated commercial readiness plans.
- Coordinate readiness activities across all cGMP and supporting functions.
- Establish readiness milestones, deliverables, and decision gates.
- Monitor progress against commercial readiness objectives.
- Identify program risks and facilitate development of mitigation strategies.
- Ensure readiness activities remain aligned with business objectives and client commitments.
Product Launch & Technology Transfer Support
- Coordinate readiness activities supporting product launches.
- Support cross-functional planning for technology transfers.
- Ensure required systems, procedures, personnel, and facilities are available to support manufacturing activities.
- Track critical path activities and assess launch readiness.
Process Performance Qualification (PPQ) Readiness
- Coordinate PPQ readiness assessments.
- Ensure departments complete required deliverables before execution.
- Facilitate readiness reviews and gap assessments.
- Support development of post-PPQ action plans and lessons learned initiatives.
Commercial Manufacturing Readiness - Coordinate readiness activities for:
- Process Performance Qualification (PPQ)
- Commercial product launch
- Technology Transfer
- Inspection Readiness
- Manufacturing Readiness
- Laboratory Readiness
- Supply Chain Readiness
- Training Readiness
- Validation Readiness
- Quality System Readiness
- Client Onboarding
- Regulatory Commitments
Governance & Executive Reporting
- Develop executive-level readiness dashboards.
- Prepare status updates for leadership review.
- Facilitate readiness steering committee meetings.
- Track action items and accountability commitments.
- Communicate critical risks and recommendations to leadership.
- Escalate critical issues to leadership.
- Drive accountability for milestone completion across functional teams.
Risk Management
- Maintain commercial readiness risk registers.
- Evaluate risks impacting launch timelines, client deliverables, compliance, quality, and operational execution.
- Facilitate risk assessments with cross-functional teams.
- Monitor effectiveness of mitigation plans.
Continuous Improevment
- Develop standardized readiness tools, templates, and methodologies.
- Capture lessons learned from launches and major programs.
- Improve organizational readiness planning processes.
- Promote project management best practices.
Required Skills & Abilities
- Strong project and program management skills.
- Excellent organizational and planning capabilities.
- Ability to manage multiple complex initiatives simultaneously.
- Strong facilitation and leadership skills.
- Ability to influence without direct authority.
- Exceptional written and verbal communication skills.
- Strong risk management and problem-solving capabilities.
- Ability to operate effectively in highly cross-functional environments.
- Working knowledge of pharmaceutical development, manufacturing, and quality systems.
- Proficient with Microsoft Office Suite or related software for project tracking
Preferred Qualifications
- CDMO experience.
- Commercial manufacturing experience.
- Product launch experience.
- Process Performance Qualification (PPQ) experience.
- Regulatory inspection experience.
- Experience implementing organizational readiness programs.
Education & Experience
- Bachelor's degree in Life Sciences, Engineering, Business, Project Management, or related discipline preferred. High School Diploma required.
- 7-10 years of experience in regulated GMP manufacturing environment.
- Experience supporting commercial manufacturing, product launches, PPQ programs, technology transfers, or large-scale GMP projects.
- Demonstrated success leading complex cross-functional initiatives.
- PMP certification required.
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer
- Must be able to lift up to 15 pounds at a time
- Adheres to consistent and predictable in-person attendance
Visit to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Skills
As published by lever · 21 questions
Basics
Resume/CV, Full name, Email, Phone, Current location, Current company
Short answers (5)
- If someone from Serán initiated contact and referred you to this role, please type their name below optional
- If yes, please explain: optional
- Please indicate your desired compensation: optional
- What is your date of availability for employment? optional
- Are you subject to any restrictions related to potential employment with Serán? Restrictions include noncompetition, nonsolicitation, no hire, or confidentiality. If yes, please provide an explanation (include name of company and description of restriction without disclosing any confidential or proprietary information to Serán)
Pick from a list (15)
- Have you ever worked for Serán BioScience before?
- Do you have experience in the pharmaceutical industry?
- Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? optional
- Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions.
- As of this date, can you present evidence of your identity and legal right to work in this country?
- Would you need VISA sponsorship now or in the future?
- Can you travel if the position requires it?
- Can you relocate if the position requires it?
- Have you ever been terminated from or asked to resign from a job? optional
- I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment.
- I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán.
- I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment.
- I understand that any job offer may be contingent on me successfully passing a criminal background check/investigation. I release Serán from all claims and/or liabilities resulting from or related to the criminal background check/investigation.
- I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing.
- I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time.
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