South San Francisco Job Description Sample
Senior Associate Study Manager
- Onboard to Amgen Early Development trainings.
- Familiarize with Amgen system to immediately contribute to support activities.
- Ideal Candidate-High functioning clinical trial associate (CTA)/Junior level clinical trial manager who is able to perform daily clinical trials activities, as well take on stretch responsibilities such as writing and review critical trial documents, as well as oversee vendor startup and management
- To assist in the execution of clinical trials and to continue development of skills/knowledge in the management of clinical research.
- The incumbent will report to Clinical Research Study Manager.
- Work with the clinical trial management staff (associates and managers) to support the execution and monitor clinical studies and achieve of clinical trial deliverable.
- Monitoring of study deliverables
- Performing protocol-related site management activities
- Participating in study planning and set- up activities including vendor management, project management, and coordination of study and implementation plans
- Supporting vendor relationships
- Serving as one of the first points of contact within Early Development for study-related issues
- Contribute to the design, content, and preparation of study concept documents, clinical protocols, amendments, consent forms, study guides, monitoring plans, (e)CRFs, and subject information sheets
- Assist in the identification and evaluation of clinical trial investigators and Phase 1 and
- Phase 2a clinical research units
- Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)
- Work with the Clinical Research Study Managers and Clinical Scientist(s) to develop recruitment strategies
- Coordinate study-level investigational product arrangements and accountability and reconciliation
- Participate in, and support study teams '
- May author monitoring plans, monitor study sites, complete monitoring reports, and have more direct responsibility for study start-up activities and site management
- Coordinate activities associated with site start-up and management including review site-modified infomed consent templates and tracking of the budget and contract process
- Provide input for screening and enrolment progress
- Provide extensive clinical site/clinical field operations support by answering protocol- specific questions
- Work with the Clinical Research Study Manager and Clinical Scientist(s) to resolve patient eligibility questions and protocol deviation
- May assist with the preparation and conduct of DLRM
- Work with BSM and assay groups (i.e. PKDM, Clinical Immunology, Molecular
- Science) to coordinate shipment and analysis of clinical biological samples
- Identify barriers to screening and enrolment and provide solutions
- Support and monitor CRO, FSP and third party vendor activities, including
- relationships and training, and the development of vendor specifications and scopes of work
- Using relevant reports, identify progress of (e)CRF data collection and query resolution
- Monitor progress of studies, identify study-related trends/issues and work with the clinical research manager to implement corrective actions when necessary
- Provide input to the clinical study team for the creation of clinical study timelines and budgets
- Assist in the processing and distribution of essential documents for archiving in the
- Trials Master File
- Provide input to and maintain administrative systems (i.e., eClinical)
- Prepare and communicate regular updates to study team
- Support preparation and quality control of protocols, clinical study reports, regulatory submissions, and publications
- Continue to increase knowledge of clinical research, clinical operations, and relevant
- therapeutic area(s)
- Contribute to the continuous improvement of Early Development
- BA/BS/BSc or RN
- 3 years work experience in life sciences or medically related field
- At least one year of biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
- BA/BS/BSc in the sciences or RN
- 5 years work experience in life sciences or medically related field, including 2 years of biopharmaceutical clinical research experience obtained as follows:
- clinical research experience obtained working on industry-sponsored or industry- partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company
- Ability to understand technical, scientific and medical information
- Understanding of drug development process
- Familiar with advanced concepts of clinical research
- Advanced computer skills
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with administration of site budgets and grants with supervision
- Experience with development of prospective site-selection criteria
- Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to write and present clearly using scientific and clinical issues terminology
- Experience dealing with time demands, incomplete information or unexpected events
- Good organizational and planning skills
- Experience working effectively in a team/matrix environment
- Attention to detail
- Team work
- Written and oral communication
- Delivery focus
- Relationship building
- Policy, process and procedural conformance
- Problem solving
- Time management
Temporary Document Control Specialist
South San Francisco, CA
$33-$36 per hour DOE
Our client is an innovative leader in cell and tissue analysis powering groundbreaking insights in academic, clinical research, pharma research and biotech. Our life science analytical and preparatory systems in mass cytometry and genomics can be found in leading academic institutions, clinical research laboratories, and pharmaceutical, biotechnology, and agricultural biotechnology companies worldwide.
Our client is looking for a Temporary Document Control Specialist to join our Quality team.
- Make sure that change notices receive the required level of review and approval.
- Ensure the required actions and implementation instructions are properly documented and carried out.
- Manage the verification of required revision control.
- Make sure revised documents have been correctly entered into the document control system, and that they are properly linked to ensure full traceability.
- Assist project managers to develop and maintain documents such as meeting minutes, drawings, specifications, approvals and related items.
- Create reports of in process change notices and assist in closing actions out in a timely manner.
- Process requests for information, retrieve files and other records as needed.
- Facilitate the efforts to keep the document control system in compliance.
- Train employees on records management procedures and policies such as, documentation, retention, retrieval, destruction and disaster recovery.
- Have fun, be fully engaged and promise to have a life beyond “work”
- 2 years of experience in document control for a regulated environment (medical device preferred however pharmaceutical, aerospace and automotive considered).
- Associate Degree in a science or library technology.
- Experience with paper and electronic based document control systems including revision control, change notification, document workflow and records required.
- Proficient in Microsoft Word, Excel and Adobe Acrobat to archive, retrieve, and format files for document control consistency.
- Experience working in an ISO 9001 and ISO 13485 environment
- Familiarity with FDA QSR desirable.
Sr Associate Scientist - Biotech (Jp5163)
Job Site: South San Francisco, Ca.
Duration: Initial 5 months with likely extension
Business Unit: Oncology
3Key Consulting Inc. is looking for role for a Sr Associate Scientist with experience in in-vivo models of cancer, for a global, CA-based, bio-pharmaceutical company.
The Department of Oncology at Amgen in South San Francisco is seeking a highly motivated researcher to perform in vivo pharmacology studies aimed at elucidating mechanisms of immune-mediated regulation of tumor growth in order to develop novel immunomodulatory therapies for the treatment of cancer.
Responsibilities will include conducting, analyzing and reporting data for PD, PK and efficacy studies to support the progression of oncology and inflammation research teams.
Must have extensive mouse handling skills, including: In vivo models of cancer; subcutaneous tumor inoculations and measurements; dosing techniques (iv, ip, subQ); blood and tissue (ex. tumor, spleen, lymph nodes, liver) collection. In vitro cell culture and flow cytometry experience is a plus.
Minimum Basic Qualifications
* B.S. degree in Physical, Life Sciences or related technical discipline.
* Min 2 years' working with mouse in vivo models
- Previous drug discovery experience
- Research experience with preclinical murine models of cancer & cancer immunotherapy
- Hands on experience administering drugs through various routes
- Hands on experience with flow cytometry
- Computer literacy, especially proficiency with Graphpad Prism, Excel, Powerpoint and Word
- Excellent organizational and communication skills, along with the ability to work in a flexible team-oriented environment
Conducting in vivo pharmacology oncology studies (mouse models). Inoculating tumors subcutaneously, measuring tumors, dosing, blood & tissue collection for PD, PK and efficacy studies. Working both independently and as part of a team to execute studies and to collect data
Top Must Have Skill Sets:
- Extensive hands on experience with in vivo models of cancer: subcutaneous tumor inoculations and measurements; dosing techniques (iv, ip, subQ); blood and tissue (ex. tumor, spleen, lymph nodes, liver) collection
- Computer literacy, especially proficiency with Excel, Powerpoint and Word (Graphpad Prism a plus)
This is a good opportunity to join this team at Amgen and gain exposure to this industry.
NOT looking for over qualified candidates. A PhD candidate will not be considered for this role.
No in vivo experience is also a red flag.
Phone interview followed by in-person interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
Account Manager With IT Staffing Experience
Type of role: Salary plus commission (full-time or part-time)
Location: Near Foster City, CA
An established IT staffing company seeks an experienced Account Manager to take over customer account management responsibilities with existing clients in the South San Francisco area, preferably someone who lives in or near Foster City.
We are looking for an Account Manager to strengthen and create long-term, trusting relationships with our existing customers. The Account Manager’s role is to interact with customers, develop new business from existing clients and actively seek new sales opportunities. You will acquire and clarify technical requirements, follow up on candidate interviews and work closely with the recruiting team throughout the sales, recruiting, placement and on-boarding process.
The successful applicant will focus on acquiring additional customers from existing client companies who can benefit from our service offerings, as well as strengthening ties with existing customers. As Account Manager, you will be responsible for meeting weekly with client managers while maintaining a high level of customer satisfaction and professionalism. You will report to the VP of Operations and manage a minimum of 4 to 6 accounts at any given time.
We’re looking for a self-motivated sales-oriented professional who values productivity and customer engagement. You will have the ability to work remotely from your home office, but will be expected to be on-site with customers at least three days per week. This position can be structured as full time or part-time (three days per week minimum), and offers a modest base salary with generous commissions.
- Bachelor’s degree required
- 2+ years of experience in account management, preferably in the IT staffing industry
- Advanced problem resolution skills and communication abilities
- Excellent ability to interpret complex technical requirements and seek appropriate clarification from clients when necessary.
- Ability to acquire and clarify customers’ needs and match them with appropriate candidates and skill sets.
- Comfort with working with IT managers and directors in a professional fast-paced environment.
Specialist IS Analyst
- Windows Upgrades:
- Configure and deploy Windows 10 based laboratory systems using Amgen’s pre-defined lab image to support laboratory instruments.
- Work with the scientists for functional testing and acceptance;
- supporting regulatory validation steps as required.
- Maintain IT asset inventory systems during deployments
- Lab Data Remediation: Configure data management software to automate movement of data from lab instrument computer systems to Amgen enterprise fileshares.
- General Ticket Resolution: Actively respond to incidents and requests for all laboratory software and systems.
- Perform system administration of both local and enterprise laboratory software and systems including:
- user account management, licensing management, Tier 1 incident response and troubleshooting.
Use ServiceNow to track service requests and/or escalate issues when necessary and to keep Amgen asset inventory up-to-date.
Additional tasks may include:
- Physically inventory laboratory computers and reconcile with laboratory inventory system
- Support corporate deployments of anti-virus, software patches to laboratory computers
- Partner with Instrument vendors on system requirements, setups and configurations for new systems as well as upgrades to existing systems.
- Develop and maintain administration tools for the Enterprise Benchtop team primarily in C#, ASP.NET, SQL and IIS
- Amgen is seeking to engage a Specialist IS Analysts with windows administration expertise to join the Enterprise Benchtop Services team for a 1-year assignment.
- The position will perform Windows system administration for laboratory-based computer systems used to control laboratory instruments (instrument controllers).
- The IS Analysts will work closely with scientific functional groups to install, configure, test, maintain, and troubleshoot lab workstation hardware and software.
- This position will be specifically focused on upgrading Amgen’s lab IT assets from Windows 7 to Windows 10 and supporting processes to ensure proper instrument data management.
- There are over 2000 instrument controllers (computers used to run lab instruments) that need operating system and data management remediation.
- The role will also work on general lab IT system problem tickets as reported by lab scientists.
Research Associate, Protein Sciences
Surrozen is a biopharmaceutical startup founded by world-leading scientists from Stanford University, Drs. Chris Garcia, Roel Nusse, Calvin Kuo and Claudia Janda. The company is focused on harnessing the Wnt pathway to identify novel therapeutics for regenerative medicine, leveraging breakthrough insights from its founders in protein engineering, stem cell dynamics, and fundamental Wnt biology.
Surrozen is seeking a creative, self-motivated individual with a passion for experimental science to join our founding team. This is a fantastic opportunity to work on cutting edge science and take part in building an exciting, science driven company.
- A Bachelors or Masters degree in Bioengineering, Protein Biochemistry or related disciplines. Industry experience is a plus
- Prior experience with mammalian cell culture for recombinant protein expression
- Experience in recombinant DNA technologies
- Ability to work in a highly dynamic and fast paced environment to contribute to multiple projects
- Extra attention to detail, self-motivation, and creative thinking are essential
- Excellent organizational, written and verbal communication skills
- Produce a wide variety of recombinant DNA clones
- Produce a wide variety of recombinant proteins, including antibodies, protein complexes, and membrane proteins
- Perform small to large scale recombinant protein expression in baculovirus and mammalian cell (HEK, CHO) systems
- Optimize expression systems to maximize protein production output and product quality
- Measure the protein-protein interaction affinity (e.g., Wasatch, Carterra, Biacore, Octet)
- Stable cell line generation and managing cell inventory
- Coordinate activities with functional groups and project teams
- We offer a dynamic start-up environment and a collaborative, passionate team
- Excellent benefits, including competitive employer contributions
- Stock options
- Paid vacation, sick time and holidays
- Shuttle service to/from Caltrain, BART and the SSF Ferry
- State of the art research facility complete with bowling alley and onsite gym (see the amenities available at The Cove)
Senior Scientist, Protein Sciences
Surrozen is seeking a creative, hard-charging protein biochemist to join its talented and passionate Protein Sciences team.
- PhD in Biochemistry, Structural Biology, Molecular & Cell Biology, or related disciplines
- Well versed in protein and antibody engineering
- Strong understanding of how protein ligands activate key cellular pathways
- Demonstrated scientific productivity as evidenced by a strong publication record in top tier journals
- Optimization of lead molecules to tune specificity, potency and affinity
- Establish and optimize protein expression systems and develop purification strategies
- Utilize high affinity antibody binders to design and express novel bispecific antibody drug candidates in mammalian-based systems
- Drive studies to elucidate protein-ligand interactions to inform engineering of novel molecules
- Explore and engineer next generation target molecules
- Collaborate closely with a fully integrated team to make key decisions on program progression
- Manage two or more direct reports
- Stock options
- Paid vacation, sick time and holidays
- Shuttle service to/from Caltrain, BART and the SSF Ferry
- State of the art research facility complete with bowling alley and onsite gym (see the amenities available at The Cove: http://leasing.covessf.com/toc.cfm
Associate, Regulatory Affairs
At Alector, our mission is to harness the power of the immune system to cure neurodegeneration and cancer. Our team integrates experts in key biotechnology disciplines and is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported on this mission by leading investors including OrbiMed, Polaris Partners, Google Ventures, Deerfield Management, Foresite Capital, Federated Kaufmann Fund, and many others. Among our strategic backers and partners, we are aligned with some of the most innovative pharma companies such as AbbVie, Merck, and Amgen.
As a Regulatory Associate for the regulatory team, you’ll work closely with the Regulatory Project Manager to prepare and drive regulatory submissions forward with a high level of quality. You will be able to contribute across a variety of programs and have broad involvement in work central to Alector’s strategic goals. You will apply your existing skills, learn new skills, and play a key role in development of the programs. As an early hire, you’ll be influential in championing and developing Alector’s culture.During the first year, your goals will include:
- Participating in the preparation of document packages for regulatory submissions (pre-IND, scientific advice, INDs, CTAs)
- Compiling documentation for US and Global submissions and becoming the go to person for project status
- Initiating and coordinating full team participation in annual reports and other routine submissions
- Taking ownership of the internal technical report publishing process
At Alector, we believe that high-performing teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a cure, where you’ll drive growth, this is the role for you. There is no limit to how far you can go with us.
We'd love to hear from you if:
- You take pride in being persistent, self-motivated, and efficient
- You thrive in an environment where we work independently and on teams
- You have 1-2 years of full-time work experience in the Pharmaceutical/Biotech Industry. Experience in a Regulatory Affairs/Regulatory Operations capacity is a plus
- You are detail oriented and take pride in quality
- You have previously participated in preparing regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities
- You have experience handling deadline dependent documents containing sensitive information
- Your academic background includes a B.A. or B.S. in a scientific or medical field
- You have a point of view but are low ego
While we’ve focused on what to look forward to during the first year and beyond, Day One is great, too: committed and driven colleagues, a bold and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these matter only if you’re excited to build and own something great, and tackle these challenges with us. Come join us.
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology company, is seeking a CMC Scientist to be part a team responsible for the Chemical Development and Regulatory strategy leading to the IND and NDA filing of new chemical entities. Our pipeline includes KZR-616, a selective inhibitor of the immunoproteasome currently in clinical trials, and multiple drug discovery programs targeting protein secretion pathways for the treatment of cancer and autoimmunity. This is an exciting opportunity to significantly contribute to the research and development of novel therapies for life-threatening diseases.
-Facilitating technology transfer and troubleshooting with CMOs
-Process development work including optimization of routes to target APIs, starting materials, and intermediates
-Synthesis and characterization of impurities and degradation products
-Conducting spiking experiments in support of pre-validation studies
-Performing crystallization studies on intermediates and final APIs
-Writing experimental protocols, regulatory documents, and technical reports
-Providing guidance and support to analytical and drug product departments
-Carrying out support tasks required to maintain a functioning chemical laboratory, such as ordering required supplies and some potential instrument maintenance
-Preparing and following standard operating procedures
-Conducting safe laboratory work practices
-Presenting results at departmental and company meetings
-M.S. or Ph.D. degree in Organic Chemistry
-2+ Years experience in the pharmaceutical industry
-A broad range of functional expertise in modern synthetic organic chemistry
-Experience in HPLC method development is preferred
-Knowledge and understanding of current Good Manufacturing Process (cGMP) requirements
-Experience working with contract manufacturing organizations is strongly preferred
-Strong written and verbal communication skills
Computational Biologist / Bioinformatics Data Scientist
Encoded is a therapeutics company funded by world-class healthcare investors Venrock, Arch Venture Partners, Illumina Ventures, and Matrix Capital Management. At Encoded, we are combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases.
We are at an exciting stage in our growth as we are generating large amounts of unique data from our proprietary, high-throughput screens. We are looking for a talented and experienced Computational Biologist/Bioinformatics Data Scientist to join our R&D team. This is a great opportunity for someone to come in early and have a big impact as we are building out the computational team at Encoded.
This position offers the opportunity to work with large genomics datasets where machine learning techniques combined with a deep understanding of regulatory biology will yield ground breaking results with direct implications for therapeutic strategies. Responsibilities will include:
- Understanding the data we are generating with our in-house technologies. Identify relevant publicly available datasets/publications that might inform our analysis of these datasets.
- Partner with other members of the computational group as well as the broader technology team to explore computational approaches relevant to answer the questions.
- Communicate the findings to rest of the organization to inform future experiments.
- Analysis and interpretation of various types of genomic data
- Integrative analysis combining different types of biological evidence
- Working with transcriptomics data is a must
- Exposure to epigenomic data and single cell data
- Understanding of regulatory genome biology
- Some familiarity with functional screens
- Exposure to data analysis for specific clinical/drug discovery projects
- Computational biology techniques relevant for NGS data.
- Machine learning techniques and their application to solving real-world biological problems
- Knowledge of standard statistical tools, such as R, SAS or MatLab, and of a general scripting language such as Python, Ruby, Perl or Groovy.
- Exposure and interest in deep learning
- PhD or MS in computational biology or related field
- Demonstrated desire and skills to work in a collaborative setting is critical
- Strong biological background and computational expertise
- Independent and creative thinking
- Drug development experience is a plus
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked kitchen
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.
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