MSAT Sr. Analytical Chemist

Corden Pharma Colorado

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 Completes troubleshooting, process & compliance improvements, and potential introduction of new analytical technology. Continuous improvements include, but are not limited to, cleaning development, waste stream analysis, in process and release testing, and raw material specifications for commercial products. A key function of this role is to help reduce operating costs and defects while maintaining high throughput and overall compliance. This role will also directly support investigations into processes in commercial manufacturing and work on continuous improvements for the Production Department.

Requirements

A PhD or BSc in Chemistry/Analytical Chemistry or equivalent combination of education and work experience.
Two years of practical work experience in API pharmaceutical processing, if holding a PhD or six years of practical work experience with a BSc; including all aspects of analytical chemistry support from scale-up and API Regulatory approval processes.
Advanced communication skills necessary to interrelate with external customers and other departments within the company structure.
Ability to write reports, proposals, contracts, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to convert units of measurement.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Communication – excellent oral and written communication
Analytical Methodologies – HPLC/UPLC, Mass spec, GC, HS-GC, IR, UV, IC, ICP-MS, NMR, and other common techniques supporting commercial production, IPC testing, and drug substance testing (and associated instruments)
Regulatory Compliance – Excellent working knowledge of ICH Guidelines, compendia (USP/EP/JP), and FDA regulatory guidance documents. May support audits/inspections as a subject matter expert
Basic troubleshooting for analytical methods
Quality Compliance – Performing and supporting investigations, determination of root cause and preventative measures

Nice To Haves

Green Belt or Black Belt certification is a plus.

Responsibilities

Ensure cGMP compliance, compliance to internal procedures, accuracy, and scientific soundness in support of commercial production
Accountable for robust procedures and reports supporting commercial manufacturing as well as incoming commercial products (Phase III or undergoing validation). Supports analytical technology transfers as part of a team
Supports commercial production and is accountable to drive higher throughput, lower costs, and improved robustness through continuous improvement of analytical methods and material specifications
Develops, authors, or reviews analytical methods and specifications for commercial products (raw materials, intermediates, drug substances), including change controls
Aids in support of vendor changes to raw materials, or specifications, or improvements. These areas both for legacy processes as well as new incoming processes
Works with a team to implement technology transfers for new analytical technology, or techniques that are required for commercial processing, or will help drive improvements for the site
Works on the establishment, implementation, and maintenance of a system of work standards within the framework of site procedures and regulatory guidance for MSAT activities
Accountable to conduct root cause analysis for analytical related failures and identify correct preventative and corrective actions from their own investigation
Collaborates with Quality Control and Development to help tech transfer methods and ensure knowledge sharing across groups to drive standard work across departments in regards to analytical methods
Works with Operations Department, Deviation Team, Training Group, and Analytical Development to identify larger trends with analytical methods or analytical failures; and ensure appropriate CAPAs, and follow on projects, or update to current standards

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 Maternity/Paternity Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance