Mgr., Process Chemistry

Corden Pharma Colorado• Boulder, CO, US, CO

8h•$165,000 - $195,000•Onsite

About The Position

Responsible for providing department-level leadership for the Synthetic Chemistry Department in accordance with the organization's policies and applicable regulatory requirements. The Manager’s responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The incumbent is responsible for creating an environment that encourages technical excellence, developing and coaching technical staff to improve skills, and ensuring high quality technical work. The Process Chemistry Department is responsible for the development of cost-effective, robust processes for the manufacture of products within the scope of the Corden business plan as well as continuous improvement, when needed, of the existing manufacturing processes.

Requirements

Ph.D. in Chemistry or equivalent and 7 years’ experience in pharmaceutical drug substance area development/production.
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, public groups, and/or 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 apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.
Ability to deal with a variety of abstract and concrete variables.
Ability to analyze manufacturing requirements and translate requirements to strategies that can be articulated and implemented in a manufacturing setting
Understanding of the basic science and engineering associated with the manufacture of pharmaceuticals
Project management skills: planning, staffing, organizing, directing, and controlling
Analytical problem-solving skills
Working knowledge of regulatory issues in pharmaceutical manufacturing
Communication – excellent oral and written skills
Administration - able to organize group to achieve group goals and objectives
QbD – able to organize and execute development/transfer projects to support Quality by Design principles
Regulatory Compliance – Excellent working knowledge of ICH guidelines/USP/EP/JP, SME for regulatory, and quality inspections
Quality Compliance – Performing and supporting investigations, determination of root cause, comprehensive knowledge of industry quality standards for method development, validation, and documentation
Tech Transfers – Experienced in writing protocols, justifications, reports, etc.

Responsibilities

Responsible and accountable for all aspects of project performance within their group. Including meeting technical, timeline and budgetary objectives as well as overall Client satisfaction
Ensures the Project teams are adequately resourced to meet project objectives by reallocating pool chemists. Including meeting technical, timeline and budgetary objectives
Identifies technical, business, client-facing and interpersonal skill development needs of the members of the department and recommends appropriate training, either formal or on the job, and ensures training occurs
Manages performance of group leaders according to Corden standards, job descriptions, departmental and company goals
As a member of the Development Management, assists in setting goals, milestones, and completion dates; evaluates and determines resources (staffing, team makeup)
Serves as an SME for internal and external customers. Ensures customer satisfaction and completion of deliverables on time and in full
Utilizes metrics and work plan to track and continually improve process performance
Identifies and provides development opportunities for team members
Observes compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating techniques in the labs, production areas, and office areas. Complies with all Quality, Environmental and Occupational Health and Safety policies and procedures, and governmental regulations
Provides leadership to the members of the department. Facilitates resolution of technical and interpersonal issues within the work group and between other work groups, providing performance feedback, work planning and addressing complaints and resolving problems.
Responsible for developing the budgets for the Synthetic Chemistry department and ensuring expenses are within the budgets.
Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.
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.

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