Program Manager II at TriLink BioTechnologies

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Apr, 26

Salary

96055.0

Posted On

21 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Leadership, Interpersonal Skills, Biotechnology, Pharmaceuticals, GMP, Regulatory Requirements, Customer Engagement, Problem Solving, Collaboration, Risk Management, Communication, Technical Knowledge, Drug Development, Quality Systems, mRNA

Industry

Biotechnology Research

Description

Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our CDMO team as a Program Manager II. As a Program Manager II you will be responsible for end-to-end management and ownership of GMP Services programs execution at TriLink. The Program Manager II is the single point of contact for GMP Services programs, interfacing with Operations, Commercial, Process Development, Quality, Engineering, and other teams to meet customer timelines and deliver milestones. The Program Manager II is expected to be a client’s advocate within the organization and actively problem solve to ensure excellent customer service, and deliver on timelines. This role is expected to fully manage and own customer contractual deliverables and use organizational and collaboration skills to lead cross-functional project teams with internal business and technical partnership to ensure that the contractual obligations are met. The Program Manager II will also apply their technical knowledge and problem-solving abilities to help overcome program challenges and make recommendations to help meet customer expectations. How you will make an impact: Directs, leads, and motivates multi-disciplinary project teams to deliver customer GMP Services project milestones from pre-Clinical through to Commercial phases, while also supporting customer engagement by being a liaison between the customer and internally facing teams. Actively manages up to 3+ small to medium size and complexity customer drug development and manufacturing programs. Actively manages contractual obligations and milestones and flags to their management when additional scope is identified requiring a new proposal, Change of Scope, or there are billing, audit requests, or other items that arise. Facilitates regular and effective internal & customer-facing team meetings that drive collaboration including structured agendas, integrated schedules, key performance measures, risk/issue management, timely communication of meeting minutes, action items and other. Maintains accurate project timelines and other related Project Management tools, and has intimate knowledge of all programs under management and works with Leadership to proactively identify and escalate potential risks and opportunities to mitigate to ensure that programs are kept on-track. Facilitates regular meetings internally and with clients to monitor and manage progress of project execution to the Statement of Work and work through open items to ensure milestone delivery. Participates in internal operating mechanisms and reports-out to PgM Leadership on the overall progress of programs along with potential risks & opportunities, customer health, and other metrics where appropriate. Perform other functions and duties as required. The skills and experience that you will bring: Bachelor’s degree in Business, Engineering, Life Sciences, or a related field, with 2-4+ years of relevant experience in customer-facing project/program management and/or customer-facing technical roles. Applicants with a master’s degree or higher may have 0-2 years of direct experience. Direct experience in biotechnology/pharmaceutical industry working in pre-IND to late-phase clinical drug substance and drug product development. Adjacent project experience in CDMO environment may count towards years of experience. Direct experience working within a CDMO managing client’s program portfolio, or relevant experience operating within a CDMO Project Core Team, required. Working knowledge of CMC considerations with respect to quality systems, GMP, ICH guidelines, FDA, USP, and associated regulatory requirements required. Excellent leadership and interpersonal skills required. Project management experience with direct management of projects required, or experience managing a broader project portfolio or participating within project teams, including experience utilizing key programs in an Operations environment such as MS Project, Smartsheet, MS Office, and ERP systems such as NetSuite. Strong interpersonal skills with demonstrated ability to build relationships within a matrixed organizational environment. Experience with the manufacture of mRNA and plasmids is a nice to have. The anticipated salary range for this position is $84,851 - $96,055. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role. #LI-Onsite The benefits of being a #MiracleMaker: You have the potential to change, improve, and save lives around the world. You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans. We offer comprehensive medical plans and HSA/FSA options. Fertility & family planning assistance. A variety of additional optional benefits and insurance options, including pet insurance. Retirement contributions. Holidays & Paid Time Off. Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/ To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/ Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Click here to view Maravai LifeSciences Privacy Notice HIRING SCAM ALERT Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.) Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment. Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov.

Responsibilities

The Program Manager II is responsible for end-to-end management of GMP Services programs, acting as the single point of contact and ensuring customer timelines and milestones are met. This role involves leading cross-functional teams and managing contractual obligations while advocating for clients within the organization.