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Position Summary
Reporting directly to the CSO, the Director of Quality Assurance (QA) is responsible for establishing and administering quality systems supporting compliant nonclinical laboratory study Good Laboratory Practice (GLP) and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies Good Clinical Laboratory Practice (GCLP). Assure Test Site Management (TSM) that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations.
Key Responsibilities
Host client and regulatory inspections including preparing responses of findings thereof.
Supports organization regulatory professionals across BABM sites.
Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance
Establish and maintain a state of inspection readiness including site specific folders.
Establish company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations.
Establish and administer a company Master Schedule.
Establish and administer QA Standard Operating Procedures (SOP’s), QA Files, and QA Audit Log.
Assure QA department inspection reports and any other supporting documentation or required records are processed and archived, as appropriate.
Monitor regulatory landscape and interpret regulatory requirements for application to business processes and procedures.
Authors and/or review Standard Operating Procedures (SOPs) and Statistical Analysis Plans (SAP).
Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance.
Provide GLP and GCLP training.
Recruits, develops, manages, and mentors regulatory professionals and helps create a supportive and growth-minded culture.
Plan, conduct and report inspections of the internal facilities to TSM.
Plan, conduct and report audits of external vendors to assess compliance with regulations, industry standards, and best practices.
Establish and administer a company Risk Register.
Identify regulatory compliance issues and provide regulatory support to departments.
Provide TSM with monthly status reports the company's compliance with GLP and GCLP regulations including problems and corrective action.
Represent QA in company meetings.
Qualifications and Educational Requirements
BA/BS degree in biological/physical sciences required. Advanced degrees (MA, PhD) preferred.
10+ years relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/ pharmaceutical industry or a combination of education and experience
Able to provide regulatory leadership and guidance on cross-functional teams and work in a matrixed environment.
A business leader, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
How to Apply
CV can be e-mailed directly to: Lea_Liu@crystalpharmatech-global.com. Be sure to denote the Job Title of the position you are applying. Please visit our website at: www.crystalpharmatech.com
Job Description
We are currently seeking a full-time Operation Specialist to join Crystal Bio Solutions, a California-based company wholly owned by Crystal Pharmatech Inc. He / She will perform a variety of operation duties partnering closely with Senior Operation Manager in supporting day-to-day operations and department-specific strategies and functions. This position will be based in Pleasanton, CA or Cranbury, NJ.
Core Responsibilities
Procurement
Manage daily company-wide procurement requests.
Identify vendors, request quotes, negotiate for price and payment terms, issue purchase orders.
Process purchase requisitions, purchase orders, stock-in forms and invoices on a daily basis in the internal procurement system.
Manage vendors’ accounts.
Coordinate with Finance Department in China Headquarter for accounts payable related questions.
HR/Admin & Operation
Assist with HR related duties as assigned.
Assist with office and lab related admin and logistics work as assigned.
Assist CA based co-workers with ad hoc duties and proactively provide support as needed.
Responsible for inbound and outbound sample shipments.
Qualifications Requirements
Bachelor's degree.
Bilingual Mandarin Chinese and English preferred.
Exceptional verbal and written communication, interpersonal, organizational, diplomacy, problem-solving, and multi-tasking skills.
High-energy professional with demonstrated self-confidence, high integrity, reliability, flexibility, attention to detail, and an ability to maintain strict confidentiality of data and information.
Open-minded to adapt to changes and learn new skills and knowledge in a fast-paced work environment.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, etc.).
Benefits
PTO and Paid Sick Leave
Annual Bonus
401(K) Retirement Plan
Medical/Vision/Dental Insurance
Wellness Program
Life insurance & Long-term/Short-term Liability
Visa Sponsorship
The candidate should have work authorization in the US. The company can sponsor work visa and green card for qualified employees in compliance with its Visa Sponsorship Policy.
How to Apply
Resume can be e-mailed directly to: Career_Us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Job Description
Crystal Pharmatech is looking for an individual business development professional to improve our brand recognition, find and cultivate business opportunities to drive sustainable financial growth through boosting sales, and forging strong relationships with clients in the small to mid-size biotech and pharma sectors in North America. The BD Manager/Director position will report directly to the head of US Business Development.
This BD Manager/Director position is primarily a work-from-home position with significant travel required. Preferred locations is San Diego.
Roles and Responsibilities
Identify, research, and develop future business development opportunities
Arrange business meetings with prospective clients; Promote the company's services addressing or predicting clients'objectives
Develop new proposals and secure new business with technical team support
Update or establish pricing and proposal structures for expansion into new services
Monitor monthly, quarterly, and annual BD proposals and review them with the Head of US BD regularly
Keep a record of client and opportunity data collection and integrity in CRM tool (e.g., Track and report the status of upcoming opportunities, calculate and track corporate win rates regularly)
Work closely with the R&D team and Project Management team to streamline project execution and completion
Work with the US Business Development Team, as well as Operations to ensure consistent messaging and approaches on projects, proposals, and marketing materials
Attend company's marketing events and industry conferences; advice on marketing or BD strategies to enhance the company's branding and generate new leads
Work closely with Crystal Pharmatech's CRO and CDMO sites in China for client introduction, technical evaluation, and introductory meeting
Qualifications
Possess a PhD, MS or BS in Chemistry, Chemical Engineering, Pharmaceutical Science or related field
Experience at a solid state research or crystallization development, CMC, formulation development. CRO/CDMO experience is highly preferred
Ability to work effectively as an individual or a part of a team and to exhibit effective interpersonal, communication and networking skills
Understands clients' needs and proactively develop business needs
Up to 50% domestic travel is required, occasional international trips, daily/overnight
Physical Requirements
Be able to travel for long distances in various methods of transportation (i.e. car, airplane, shuttle bus, etc.)
Be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop
Benefits Visa Sponsorship
PTO and Paid Sick Leave
Quarterly Commission
401(K) Retirement Plan
Medical Insurance
Wellness Program
Visa Sponsorship
The candidate should have work authorization in the US. The employer can sponsor work visa and green card for qualified employees in compliance with the company's Visa Sponsorship Policy.
How to Apply
Resume can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Crystal Formulation Services Co., Ltd.,
Crystal Formulation Services (CFS), a wholly owned subsidiary of Crystal Pharmatech Co., Ltd., was founded in July 2021 in Suzhou, China. CFS provides oral formulation development and manufacturing services of innovative drug products to pharmaceutical companies around the world.
As a formulation CDMO, our core technical team possess rich drug product development experience (worked on more than 100 new chemical entities (NCE),19 of which have been successfully commercialized). We embrace a molecule-material-medicine (M3) philosophy, whereby we set the formulation strategy of any given NCE according to its clinical needs, molecular properties and API characteristics and develop the most suitable composition and process to make the envisioned formulation a reality. Our technical strength is a deep understanding of the interplay among material properties, formulation process and product performance. The M3 philosophy and technical strength enable CFS to deliver, right the first time, robust formulations tailor-made for our clients’ molecules that are bioavailable, stable, and scalable with a line of sight to market and commercial production. We dive deeply into oral formulation science and strive to become a first-class CDMO in this area.
Job Description
The BD salesperson is responsible for developing formulation CDMO and clinical supply business in the US market, identifying and nurturing client opportunities to increase CFS' revenue and market share. Responsibilities also include effectively acquiring new business in small and medium-sized biotech as well as large pharmaceutical companies. The BD sales person will directly report to the Head of Business Development of CFS (China) with a dotted line to the US BD head of Crystal Pharmatech.
This BD sales position will be primarily based on the west coast of the US with travels across the country on special business needs, e.g. conference, company meeting, etc.. It is a work from home position with flexible working hours. The position is based most preferably in the San Francisco Bay area, though San Diego or Los Angeles area can also be considered.
Roles and Responsibilities
Serve as Business Development Representative in the US for CFS CDMO and clinical supply business and perform all associated duties as resourcing requires; Interact with clients as needed to explain Company’s operational strategy and related budgeting approaches; and conduct pricing negotiations
Responsible for the client and opportunity data collection and integrity in CRM tool(e.g., Track and report the status of upcoming opportunities, calculate, and track corporate win rates on a regular basis)
Identify CDMO business opportunities and secure them by getting the BDM or SME to the client meeting. Advises BD team on prospecting and closing new projects. Monitor monthly, quarterly, and annual BD proposals and review with the global team on regular basis.
Work closely with R&D team and PM team to streamline project execution and completion
Responsible for development and management of annual BD budget for the US market
Work with the CFS Business Development Team, as well as Crystal Pharmatech US BD team to ensure consistent messaging and approaches on global projects, proposals, and marketing materials, attend annual marketing events at industry conferences
Qualifications Requirements
High school, BS, or MS Degree (scientific/engineering disciplines preferred but not excluding liberal arts fields) with 0-3 years of business development experience
Strong passion for sales with entrepreneur mindsets
A people person with excellent interpersonal, communication and networking skills
Proactively explore business opportunities and develop business needs
Experience or background with science and engineering, formulation development, CRO/CDMO is preferred
Ability to work effectively as an individual or a part of a team
Understands clients' needs and proactively develop business needs
Up to 50% travel is required, domestic, with occasional international travels (e.g., China, Europe)
Physical Requirements
Be able to travel for long distances in various methods of transportation (i.e. car, airplane, shuttle bus, etc.)
Be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop
How to Apply
CV can be e-mailed directly: cfs_recruit@crystalpharmatech.com
Please denote the Job Title of the position you are applying for.
Job Description
The Associate Research Scientist will report directly to a Senior Research Scientist and handle all areas of solid-state research applied to API and early formulation development. This includes crystal form screening, single crystal growth, early formulation development, and all aspects of physicochemical characterization. The candidate will develop experimental designs and must actively communicate across multiple functional areas. The ideal candidate should have the following qualifications:
Possess B.Sc. or M. Sc. degree in Chemistry, Pharmaceutical Science, or related field.
Must have hands-on laboratory experience with a research project and report writing during undergraduate studies, internship, or Master of Science studies; or minimum 1-year industrial lab experience is required.
Demonstrate a fundamental understanding of the scientific principles governing the above-mentioned research project or industrial lab work.
Fundamental general chemistry and physical organic chemistry knowledge (the knowledge will be tested during the interview).
A background in topics including thermodynamics, polymorphism, crystallization, API, and formulation process development is preferred.
Hands-on HPLC experience is a plus.
Display excellent lab skills with the ability to quickly learn instrumentation.
Display a high-level of innovation and practical ingenuity.
Always diligent in scientific rigor displaying a high-level of integrity.
Roles and Responsibilities
Crystal form screening, scale-up, full characterization.
DSC, mDSC, TGA, KF, GC, HPLC, XRPD, PLM use and data interpretation.
Single crystal growth.
HPLC method development.
Instrument use and theoretical training will be provided during the 3-month probation period.
Benefits
PTO and Paid Sick Leave.
Annual Bonus.
401(K) Retirement Plan.
Medical Insurance.
Wellness Program.
Quarterly Project Rewards.
The employer can sponsor work visa and green card for qualified employees in compliance with the company's Visa Sponsorship Policy.
How to Apply
CV can be e-mailed directly to: rositza_petrova@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
