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Job Description
We are currently seeking a full-time, entry-level Operation Specialist to join the Crystal Pharmatech team. 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 Cranbury, New Jersey.
Core Responsibilities
HR/Admin
Support Senior Operation Manager with recruitment process; assist in developing new cost-effective recruitment channels to increase the quality of candidate pool and facilitate the hiring process.
Assist with new hire onboarding process and documentation.
Coordinate with immigration lawyer to assist with employees' visa questions.
Keep track of leave of absence and update the attendance summary on a monthly basis.
Responsible for tracking the weekly and monthly project labor hours.
Assist in streamlining R&D project assignment process.
Coordinate with landlord to follow up on building and logistics related issues.
Collaborate closely with IT contractor to streamline the organization’s IT management to ensure the data security and protection practices. Regularly review IT contractor service.
Supply Chain
Responsible for inbound and outbound sample shipments.
Assist Procurement with vendor selection, quotation negotiation, invoice processing in the internal procurement system.
Assist management team with other duties as assigned and proactively provide support to the Operation division as needed.
Qualifications Requirements
Bachelor's degree.
Bilingual Mandarin Chinese 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
Health Insurance
Wellness Program
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: Lea_Liu@crystalpharmatech-global.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: Lea_Liu@crystalpharmatech-global.com. Be sure to denote the Job Title of the position you are applying.
Roles and Responsibilities
1. Responsible for the analytical methods development for oral solid dosage (OSD) products, ensuring analytical methods are fully validated in accordance with SOPs, regulatory guidelines and meet specification requirements during all phases of New Product Development.
2. Directs, plans, and oversees the analytical activities of Product development, Methods Development and Validation/Transfer, Metrology, and support OSD products process development and manufacture.
3. Design and manage stability experiments, including prototype/probe stability, IND stability, FFS study, etc.
4. Assures accurate and timely testing and reporting of all results; approves and issues technical reports which include all certification and validation data as appropriate. Presents data and summary of findings to cross-functional teams and senior management.
5. Working closely with clients to ensure project progress is on track from an analytical perspective.
6. Responsible for reviewing batch records of materials and product release testing
7. Responsible for the preparation of analytical technical documents for technology transfer executions and solving potential analytical problems during t project transfer to the manufactory in a timely manner.
8. Provides data for the preparation of CMC section of regulatory submissions, works closely with cross-functional teams to author/review CMC content and responses to regulatory authorities where applicable (such as P5-P8).
9. Responsible for OOX investigation, root cause analysis and CAPA.
10. Participate in the drafting, review and upgrade of relevant SOPs.
11. Responsible for managing and developing direct and indirect reports and actively fostering employee engagement and enablement of the team.
Qualifications
1. Ph.D. degree, graduate in analytical chemistry, organic chemistry, or related technical field, fluent in oral English.
2. More than 5 years of related hands-on experience in well-known pharmaceutical companies, and experience in CDMO industry is preferred.
3. Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance (ICH, FDA, EMA, NMPA, etc.) documents as they relate to manufacture and quality testing of pharmaceutical products.
4. Familiar with policies and regulations of new drug development, demonstrated solid management experience with stability programs in all stages of Drug Product development and manufacturing.
5. Excellent analytical development capabilities, such as analytical method development, identification of degradation and unknown impurity structures by LC-MS and NMR, etc.
6. Understand cutting-edge technologies such as Biorelevant dissolution, amorphous solid dispersions technology.
7. Scientific driving, open and optimistic, solid and resilient, good at communication and coordination, and have excellent teamwork spirit.
8. Excellent learning ability, agile to think and analyze problems thoroughly
9. Excellent execution ability, fast, accurate and ruthless.
Job Description
The successful candidate will be a leader in the Formulation Science Department who reports directly to CSO to construct, manage, and develop the company's formulation R&D department. He is expected to be responsible for the good development of formulation R&D business.
Roles and Responsibilities
1. Responsible for the development of the company's oral solid formulations.
2. Responsible for communicating with clients, including but not limited to formulation development, process exploration, technology transfer, and review of registration documents, etc., to ensure that the project is executed on time and with quality.
3. Responsible for the organization and personnel training of other research teams.
Qualifications
1. Ph.D. degree, major in pharmacy, pharmaceutical engineering and other pharmacy-related majors, fluent in English.
2. More than 5 years of relevant work experience in well-known pharmaceutical companies, and experience in CDMO industry analysis is preferred.
3. Possess excellent formulation development capabilities, and have practical experience in formulation development for multiple NCE projects.
4. Experience in early formulation development, and experience in OSD formulation development in the full life cycle is preferred.
5. Familiar FDA, EMA, NMPA regulations, technical guidelines and procedures related to product development.
6. Independent thinking and problem-solving skills.
7. Excellent leadership skills, communication and coordination skills, teamwork spirit, planning and execution skills, management and communication skills.
8. Excellent leadership, good at managing a team and a strong sense of responsibility.
9. Excellent learning ability and rigorous scientific attitude.
10. Strong ability to analyze and solve problems, pay attention to details, and be good at communication.
11. Excellent execution ability, fast, accurate and ruthless.
