Director, Analytical Research & Development

Job Description

Job Description

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• 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

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides direct leadership to functional managers and their direct reports. Carries out leadership responsibilities in accordance with the policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; is the principal decision maker in recruiting and hiring; and in making salary recommendations for the members of the department; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. 

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.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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.

QUALITY RESPONSIBILITIES

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

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.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

Must be able to travel both domestically and internationally.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level is typical of an office environment.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

 

SALARY

Actual pay will be based on your skills and experience.

 

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