Director, Analytical Research & Development

Corden Pharma Colorado• Boulder, CO, US, CO

14h•$195,000 - $215,000•Onsite

About The Position

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being. Our People Vision We strive for excellence. We share our passion. Together, we make a difference in patients' lives. SUMMARY Responsibilities include setting and achieving objectives consistent with site strategy, analytical method development and validation for peptides small molecules APIs. Developing and monitoring plans to meet outlined objectives, building employee capabilities consistent with site needs, and embedding continuous improvement in our day-to-day activities. Provides strategic Analytical Technical leadership and management for the Analytical R&D Department at the Corden Pharma Colorado site. Leads the design, development, and validation of analytical methods supporting peptide programs. Provides Analytical R&D leadership to drive high performing Development teams, effective cross-collaboration with other departments, and inspires confidence in site’s technical capabilities. Ensures that standard work and tactical plans for Analytical Development activities are organized and results are achieved, consistent with customer expectations and site objectives. The Analytical R&D Department is responsible for technical support of plant operations that include developing or transferring new analytical methods to support early phase clinical GMP programs, as well as validating analytical methods for late phase commercial products. This position requires a hands-on expertise managing large teams in a CDMO environment, with deep analytical technical knowledge of peptides and peptide related products, and expertise in various analytical techniques from HPLC, UPLC, SEC, LCMS/MS, CHN, AAA, IC, ICPMS, KF, IR, Raman, etc. Drives best practices through active participation across site R&D Development strategy and plan. Member of the Development organization’s Leadership Team responsible for sustainable profitable growth.

Requirements

Doctoral Degree (PhD) or equivalent in Chemistry, Analytical Chemistry, or related field with 15 years of experience in the development of API, particularly with a focus on Peptide APIs; or equivalent combination of education and experience.
Experience developing CMC strategies and successfully executing on ICH Compliant methods development and validation.
Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, scientific and public groups, as well as to boards of directors.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with multiple abstract and concrete variables.
Must be able to travel both domestically and internationally.
Understanding of basic science and engineering associated with the manufacture of pharmaceuticals
Demonstrated expertise in Analytical Development and Operations Management. Well versed with QbD approach, and all ICH regulatory guidances and framework
Demonstrated expertise and know-how in peptide synthesis both on solid phase and in solution phase. Well versed with various techniques to characterize peptide APIs of 10-50Aas
Proven experience leading and managing high performing analytical teams
Project Management skills, planning, staffing, organizing, directing, and controlling
Analytical problem-solving skills
Working knowledge of regulatory issues in pharmaceutical manufacturing
Leadership and negotiation skills
Ability to build relationships, influence, and motivate others
Coaching and mentoring skills. Strong communication skills
Excellent written and oral communication skills and presentation skills
Experience with international environments

Nice To Haves

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; and work with hands. The employee must occasionally lift and/or move up to 25 pounds.

Responsibilities

Responsible for Technical and managerial leadership of Analytical R&D’s project portfolio. Provide scientific and operational leadership and ensure Analytical R&D meets customer expectations on budget and on time for the technical aspect of the projects; including IPC method development, release methods, starting materials and regulatory starting materials testing
Responsible for Analytical Chemistry method development and phase appropriate validation
Responsible for technical evaluation of new projects, including identification of risks, innovation opportunities, capabilities needed, cost analysis, and pricing strategy
Devise and execute long-term analytical strategies that are aligned with programs commercialization and regulatory timelines
Provide written and verbal communication to customers to ensure confidence in ability to deliver on projects. Participate in customer meetings providing strategic direction to cross functional teams
Lead development, tech transfer and qualification, and validation of stability indicating methods, by looking at accuracy, precision, specificity, robustness, intermediate precision, and stability
Review and approve validation protocols and analytical method validation reports
Oversee external partners supporting validation or external testings on behalf of CordenPharma
Ensure Analytical R&D capabilities align with strategic goals and provide competitive advantage. Ensure the proper technical resources and skills are in place and appropriately applied to meet and exceed Development goals. Provide access to external technical sources and contacts, as needed to assure leading state of science and technology
Serve as Analytical Technical Lead for Peptide Development Programs, setting CMC direction for these compounds, evaluating efficient analytical comparability strategies culminating in successful tech transfers and validation execution
Identify technical, business, and interpersonal skill development needs of the members of the management team; and recommend appropriate training, either formal or on the job, and ensure training is effective
Guide and review strategic technical work of group members as necessary to ensure a high-quality work product on technical and quality issues
Participates in developing the Corden Pharma brand
Responsible for ensuring compliance with GMP, regulatory, safety, and environmental regulations and laws for local, state, and federal
Provides direct leadership to functional managers and their direct reports.
Responsible for developing, managing the budget for the Analytical R&D Department, and ensuring expenses are within the budget.
Contributes to the direction and oversight of the operational aspects of the organization by serving on the Development site Leadership Team. Be a key point of contact for high level customer interactions and joint steering committees.
Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance